Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures

ABSTRACT

Methods, devices, and systems for a) revascularization and/or b) performing other medical procedures at vascular or non-vascular intracorporeal locations within a mammalian body. The methods generally comprise the formation of at least one extravascular passageway from a blood vessel to a vascular or non-vascular target location. In the revascularization methods the extravascular passageway is utilized for blood flow. In the medical procedure methods the extravascular passageway is utilized as a conduit for accessing or performing procedures at the vascular or non-vascular target location. Also disclosed are catheter devices and systems which are useable to form the extravascular passageways of the invention, as well as apparatus for modifying, maintaining and/or closing such extravascular passageways.

RELATED APPLICATIONS

This patent application is a continuation of application Ser. No.08/730,327 filed on Oct. 11, 1996, now U.S Pat. No. 6,190,353.

FIELD OF THE INVENTION

The present invention pertains generally to medical methods, devices,and systems, and more particularly to methods, devices, and systems fora) revasculariation and/or b) performing medical procedures at vascularor non-vascular intracorporeal locations within a mammalian body.

BACKGROUND OF THE INVENTION A. Background Relating to RevascularizationProcedures

In modern medical practice, it is often desirable to bypass segments ofartery which have become obstructed, diseased or injured. The typicalsurgical procedures used for bypassing of obstructed, diseased orinjured segments of blood vessel require open surgical exposure of theartery, and the attachment (e.g., suturing) of a tubular graft (e.g.,homograft, xenograft, allograft, prosthetic or bioprosthetic graft) tothe affected artery such that one end of the graft is connected upstreamof the obstructed, diseased or injured segment, and the other end of thegraft is connected to the artery downstream thereof. In this manner,arterial blood is channeled through the bypass graft, thereby restoringblood flow distal to the obstructed, diseased or injured segment ofartery, and preventing tissue ischemia, infarction, and other sequelaewhich may result from impaired blood flow through the affected artery.

Although surgical bypass grafting of arteries has been performed atvarious locations within the body, it is most typical for such arterialbypass procedures to be performed for the treatment of either i)coronary artery disease or ii) peripheral vascular disease affecting thelower extremities.

i. Coronary Artery Disease

Coronary artery disease continues to be one of the leading causes ofmorbidity and mortality, throughout the world. The typical etiology ofcoronary artery disease is characterized by the build-up ofatherosclerotic plaque within the coronary arteries. Such deposits ofatherosclerotic plaque tend to fully or partially block the flow ofblood through the affected coronary arteries, and if untreated canresult in myocardial ischemia, infarction and death.

For many years, the traditional surgical treatment of coronary arterydisease has been coronary artery bypass surgery wherein the patient isgenerally anesthetized, placed on cardiopulmonary bypass and thepatient's heart is temporarily stopped. A thoracotomy (e.g., a mediansternotomy) is performed and the obstructed coronary blood vessels areexposed by surgical dissection. One or more segments of the patient'ssaphenous vein or internal mammary artery is/are harvested for use asbypass graft(s). The harvested segment(s) of vein or artery is/are thenanastomosed to the obstructed coronary artery(ies) to form bypassconduit(s) around the arterial obstruction(s). Such traditional coronaryartery bypass surgery is expensive, extremely invasive, and isassociated with significant operative and preoperative complications.

One alternative to traditional coronary artery bypass surgery is balloonangioplasty. In balloon angioplasty, a flexible guide catheter ispercutaneously inserted into a peripheral artery (e.g., the femoralartery) and is transluminally advanced through the vasculature until thedistal tip of the catheter is within the ostium of an obstructedcoronary artery. Thereafter, a balloon catheter is passed through theguide catheter and into the obstructive lesion. The balloon of thecatheter is inflated one or more times to dilate the coronary artery inthe region of the obstructive lesion. These balloon angioplastyprocedures tend to be less expensive and less traumatic than traditionalcoronary artery bypass surgery. However, balloon angioplasty proceduresof this type may be associated with a significant incidence ofrestenosis at the angioplasty site. The cause and mechanism of suchrestenosis continues to be the subject of ongoing study. However, suchrestenosis has generally been attributed to either a) an increase in themass of the artery wall (e.g., neointima formation), b) a thickening ofthe artery wall without substantial change its mass (e.g., vascularremodeling) and/or c) radial contraction of the balloon-dilated arterywall upon healing of cracks and fissures that have been created by theballoon dilation process.

Another alternative to traditional coronary artery bypass surgery isintraluminal removal (e.g., atherectomy) or ablation (e.g., ultrasound,laser) of the obstructive matter within the coronary artery. Theseintraluminal removal or ablation procedures are performed by passing acatheter-mounted removal or ablation apparatus through the vasculatureto the site of the coronary obstruction. The catheter-mounted removal orablation apparatus is then utilized to cut, shave, sonicate, pulverize,or vaporize or otherwise ablate the obstructive matter from the lumen ofthe coronary artery. These procedures must be performed with caution toavoid perforation or damage to the artery wall, as such perforation ordamage can result in hemorrhage or excessive scaring and subsequentreocclusion of the artery lumen. Furthermore, these ablative proceduresmay, in some cases at least, be confounded by the need to meticulouslycontain and remove dislodged or severed fragments of the obstructivematter, in order to prevent such fragments of obstructive matter fromescaping into the patient's circulatory system. Examples of atherectomycatheters and other catheter-mounted ablative apparatus are described inU.S. Pat. Nos. 3,433,226 (Boyd), 3,823,717 (Pohlman, et al.), 4,808,153(Parisi), 4,936,281 (Stasz), 3,565,062 (Kuris), 4,924,863 (Sterzer),4B70,953 (Don Michael, et al.), 5,069,664 (Suess, et al.), 4,920,954(Alliger, et al.) and 5,100,423 (Fearnot), as well as foreignpatents/patent publications EP0347098A2 (Shiber)., W087-05739 (Cooper),W089-06515 (Bernstein, et al.), W090-0130 (Sonic Needle Corp.), EP316789(Don Michael, et al.), DE 3,821,836 (Schubert), DE2438648 (Pohlman), andEP 0443256A1 (Baruch).

Other alternatives to traditional coronary artery bypass surgery haveincluded minimally invasive endoscopic procedures which may, ostensiblyat least, be performed through small (e.g., 1-3cm) incisions formed inthe patient's chest wall, by insertion of a thoracoscope and associatedoperative instruments through such incisions. One such minimallyinvasive coronary bypass procedure is described in U.S. Pat. No.5,452,733 (Sterman et al.). If perfected, these minimally invasivecoronary artery bypass procedures may lessen the discomfort and lengthof recovery time experienced by patients who undergo such minimallyinvasive procedures vis a vis those who undergo traditional coronaryartery bypass surgery. However, endoscopic surgical procedures of thistype typically require a great deal of operator skill and training.Furthermore, as with traditional coronary artery bypass surgery, thesethoracoscopic procedures are typically performed under generalanesthesia, and typically require that one or more chest tubes be leftin place during the postoperative period to drain any blood which leaksfrom the graft anastomoses and to reduce the pneumothorax which has beenorated by the formation of full-thickness incision(s) in the chest wall.Moreover, some of these thoracoscopic coronary artery bypass proceduresrequire that the patient be placed on cardiopulmonary bypass, and thatthe patient's heart be temporarily stopped. Others of thesethoracoscopic procedures purport to be useable without placing thepatient on cardiopulmonary bypass, and without stopping the heart.However, those thoracoscopic procedures which purport to be useablewithout cardiopulmonary bypass and heart stoppage are relatively complexto perform and typically require temporary clamping or ligating of thecoronary artery which is to be bypassed. Accordingly, even thosethoracoscopic procedures which may be useable without cardiopulmonarybypass/heart stoppage are prone to unique and significant risks anddifficulties due to the complexities of the procedure and the need fortemporary clamping or closing off the coronary artery(s) being bypassed.Thus, many of the drawbacks associated with traditional coronary arterybypass surgery, as well as additional potential drawbacks, may beassociated with these minimally invasive thoracoscopic procedures.

Another previously described procedure which does not actually bypasscoronary artery obstructions but which nonetheless may be useable toimprove blood flow to ischemic regions of the myocardium, is a procedureknown as transmyocardial revascularization (TMR). In the TMR procedure atissue-penetrable probe, such as a laser probe, is utilized to formnumerous full-thickness penetrations through the ischemic myocardialwall, and into the chamber of the left ventricle. Oxygenated blood fromthe left ventricle then flows outwardly through such penetration tracts,so as to perfuse the ischemic myocardium. Examples of suchtransmyocardial revascularization procedures are described in U.S. Pat.Nos. 5,554,152 (Aita et al.), 5,380,316 (Aita et al.), and 5,125,926(Linhares et al.)

One modification of the TMR procedure requires the formation of a valvedand/or internally stented transmyocardial passageway (e.g., aninterstitial tunnel formed in the muscular wall of the heart) from theleft ventricle of the heart to an obstructed coronary artery, downstreamof the obstruction. Such modified TMR procedure, is described in U.S.Pat. Nos. 5,287,861 (Wilk), 5,409,019 (Wilk), and 5,429,114 (Wilk).

ii. Peripheral Vascular Disease

Peripheral vascular disease commonly results from the build up ofatherosclerotic plaque and/or thrombotic matter within peripheralarteries. In many cases, when arteries of the lower extremities havebecome obstructed by peripheral vascular disease, a phenomenon known asintermittent claudication results. Intermittent claudication ischaracterized by the occurrence of pain and progressive weakness in thelegs during exertion (i.e., walking or running).

The typical surgical approach to the treatment of peripheral vasculardisease, especially in patients who exhibit symptoms of intermittentclaudication, is to surgically expose the affected artery and toanastomose a tubular bypass graft (e.g., a tube of woven polyester orexpanded polytetrafluoroethylene (ePTFE)) to the affected artery suchthat one end of the graft is attached upstream of the obstruction, andthe other end of the graft is attached downstream of the obstruction. Inthis manner, arterial blood will flow through the tubular bypass graftand around the arterial obstruction, thereby restoring blood flow to theportion of the artery downstream of the obstruction.

One alternative to traditional arterial bypass graft surgery for thetreatment of peripheral vascular disease of the lower extremities, is aprocedure known as in situ vein bypass. These in situ vein bypassprocedures are typically carried out by forming at least two (2) openincisions in the leg, to expose the affected artery at sites upstreamand downstream of the obstruction. A peripheral vein, which extendsthrough the leg generally parallel to the affected artery, is thenprepared by inserting an instrument into the vein to lyse or disrupt thevenous valves located within the vein. Thereafter, any side brancheswhich extend from the vein are cut, ligated or blocked by embolization.The prepared vein is then transected at locations above and below thearterial obstruction, and the transected ends of the vein are placed incontact with, and sutured directly to, the artery at sites upstream anddownstream of the obstruction. In this manner, arterial blood flowbecomes channeled through the prepared segment of vein, such that theprepared segment of vein will act as bypass conduit around the arterialobstruction. Examples of current in situ vein bypass procedures aredescribed in White, R. A. and Fogarty, T. J., Peripheral EndovascularInterventions, Pgs., 166-169, Mosby & Co. (1996).

iii. Trauma and Other Diseases Which May Impair Flow Through Arteries

Various arteries of the body may become damaged by trauma (e.g.,lacerations, crushing injury, blunt abdominal trauma) or may becomeinvaded or compressed by extra-vascular disease processes (e.g., toproliferation and ingrowth of an adjacent tumor). The typical surgicalapproach to treatment of arteries affected by such trauma or disease isto surgically expose and direct the affected segment of artery, and tothereafter a) resect and reconnect or b) bypass the affected segment ofartery, to restore arterial blood flow through or around the affectedsegment of the artery. In many such cases, the segment of arteryaffected by the injury or disease may be so large as to preclude simpleresection, removal of the affected segment, and end-to-end anastomosisof the adjacent cut ends of the artery. Accordingly, in such instanceswhere resection and end-to-end anastomosis is not an available option,it may be desirable to attach a tubular bypass graft (e.g., a tubulargraft formed of woven polyester, or ePTFE) to the affected artery, tobypass the affected segment of the artery.

Although a number of the above-described surgical procedures representrelatively recent advancements whereby the invasiveness and riskassociated with traditional surgical approaches have been mitigated,there remains a need in the art for the development of new, safe, andreliable minimally invasive and/or transluminal procedures for bypassingsegments of arteries which have become obstructed, injured or affectedby disease.

B. Background Relating to Other Extravascular Surgical InterventionalProcedures

Many types of surgical and interventional procedures have previouslybeen formed in organs, tissues or body cavities of the body.Traditionally, access to such organs, tissues or body cavities isattained through the formation of one or more open surgical incisions inthe body, whereby the affected organs, tissues or body cavities aresurgically exposed.

In recent years, substantial efforts have been undertaken to develop“minimally invasive” surgical techniques whereby one or more endoscopesare utilized to view the affected organ, tissue or body cavity,operative instruments or other devices are inserted into the body toaccomplish the desired surgical or interventional procedure throughrelatively small, “minimal access” (e.g., less than 3 cm) incisions.

Although the advent of these endoscopic “minimal access” surgicalprocedures may have added advantages over traditional open surgicaltechniques insofar as they may minimize the size of the surgicalincision, and accordingly, may lead to less post-operative surgicaldiscomfort, such endoscopic procedures are often limited to procedureswithin accessible body lumens or cavities which may be filled with clearliquid or insufflated with a gas to provide an open area within which toplace the operative endoscope(s) and instrument(s).

In view of the limitations associated with the even the most modern“minimal access” surgical and interventional procedures, there remains aneed in the art for the development of new methods and apparatus foraccessing tumors, organs, tissues and other extravascular locationswithin the body, to permit the performance of surgical and/orinterventional procedures without the need for forming any open surgicalincisions in the body.

SUMMARY OF THE INVENTION

In general, the present invention provides methods for using thevascular system of a mammalian body as a conduit for performing varioustypes of medical procedures. Due to the wide distribution of vesselconduits throughout the body, the vascular system provides a highwaythrough which devices can be navigated to reach selected treatment siteswhich may be otherwise only accessible through a direct incision. Thespecific methods of the present invention include a) revascularizationmethods, and b) methods for performing various types of medicalprocedures at extravascular locations within the body.

The revascularization methods of the present invention generallycomprise the formation of one or more extravascular passageways betweenblood vessels, different locations on the same blood vessel, or a bloodvessel and another blood-containing anatomical structure (e.g., chamberof the heart), such that blood will flow through such passageway(s). Inmany applications of the invention, it will be desirable for oxygenatedblood (i.e., blood which has a pO₂ greater than 50) to be carriedthrough the extravascular passageway(s) for the purpose of providing orenhancing perfusion of tissues. The extravascular passageways formed inaccordance with the revascularization methods of the present inventionmay be formed by a percutaneous, transluminal approach which avoids theformation of open surgical incisions in the mammalian body. Theserevascularization methods of the present invention may be useable inperipheral blood vessels and/or in coronary blood vessels.

In accordance with the revascularization methods of the presentinvention, there are provided procedures for providing arterial bloodflow to a tissue which has been deprived of blood due to the presence ofan obstruction, injury or disease within a segment of an artery. Themethod generally comprises the step of forming a first extravascularpassageway between an anatomical conduit which contains arterial blood(e.g., an artery or chamber of the left heart), and a blood vessel whichwill perfuse the blood-deprived tissue, such arterial blood will passthrough the extravascular blood flow passageway and into the bloodvessel, so as to perfuse the blood-deprived tissue through the bloodvessel. In some applications of this method, the first blood flowpassageway will be formed between an artery and an adjacent vein, suchthat blood will flow from the artery into the adjacent vein and willsubsequently pass through the vein in the retrograde direction so as toback-perfuse tissue through the venous vasculature. Alternatively, asecond blood flow passageway may be formed between the vein and theartery wherein the obstruction, injury or disease is located, such thatarterial blood which has entered the vein will reenter the artery,downstream of the obstruction, injury or disease-affected segmentthereof, thereby perfusing the blood-deprived tissue through theendoqenous artery wherein the obstruction, injury or disease-affectedsegment is located. The medical procedure methods of the presentinvention broadly comprise the step of forming at least oneextravascular passageway from a blood vessel to another intracorporeallocation (eg.,blood vessel, organ, body cavity, tumor, etc.) andsubsequently passing a substance or apparatus through the extravascularpassageway to perform the desired medical procedure at the selectedintracorporeal location.

Further in accordance with the invention, there is provided a devicewhich is insertable into a blood vessel and useable to form anextravascular passageway which extends from the blood vessel withinwhich the catheter device is inserted to a target location (e.g., a)another blood vessel, b) another blood containing anatomical structure(e.g., chamber of the heart), c) another location on the same bloodvessel, or d) an extravascular location. (e.g., organ, tumor, bodycavity, etc.)) Extravascular passageways formed by this catheter devicemay be used for performance of the methods of the present invention, assummarized hereabove. This passageway forming catheter device maycomprise an elongate, flexible catheter body having a tissue penetratingelement (e.g., a member, device or flow of energy) which is passablefrom the catheter body, to form a passageway through the wall of theblood vessel in which the catheter is positioned, and through any othertissue located between the blood vessel and the target location (e.g.,other blood vessel, anatomical structure, extravascular location, orother location on the same blood vessel) to which the passageway isdesired to extend. The tissue-penetrating element may comprise asuitable type of tissue-penetrating member, device or flow of energy,including but not necessarily limited to hollow and/or solid needle,trocar-tipped needle (with or without a surrounding pliable sheath),laser beam, laser-emitting member, electrocautery probe, hot-tippedprobe, rotating tissue penetrating apparatus, or ultrasonic ablationprobe. Optionally, the catheter device may be equipped with suctionlumen, inflatable balloon(s) or other structural attributes or apparatususeable to facilitate or assist the passage of the tissue-penetratingelement (e.g., member, apparatus, flow of energy) from the blood vesselto the selected target location. Also, optionally, thetissue-penetrating element of the catheter device may incorporate aguide wire lumen or other means for passing a guide wire through theextravascular passageway formed by the tissue-penetrating element.

Further in accordance with the invention, the passageway-formingcatheter device of the foregoing character may be combined with one ormore apparatus for orienting the tissue-penetrating element to insurethat the extravascular passageway is formed at its intended location.Such orienting apparatus may be mounted upon or incorporated into thepassageway-forming catheter, or may be formed separately of thepassageway-creating catheter and used in conjunction with the catheter,from any suitable intracorporeal and/or extracorporeal location. Theorienting apparatus my comprise various types of active and/or passiveapparatus including, but not limited to, extracorporeal orintracorporeal ultrasound apparatus, extracorporeal or intracorporealDoppler apparatus, intracorporeal or extracorporeal radiographicapparatus, magnetic resonance imaging apparatus, tomography apparatus,induction coils, electromagnetic devices, and various catheter-bornemarkers which are identifiable by radiographic, sonic, ultrasonic,photographic, MRI, or other means.

Still further in accordance with the invention, there are providedpassageway-modifying devices for debulking, lining, stenting,longitudinally compressing and/or otherwise modifying the extravascularpassageway(s) which are formed by the present invention.

Further objects and advantages of the present invention will becomeapparent to those skilled in the art upon reading the detaileddescription of preferred embodiments set forth herebelow, whereincertain presently-preferred embodiments and examples of the inventionare set forth in detail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a front perspective view of a human heart showing thetypical locations of coronary arteries and veins thereon.

FIG. 1 b is a rear perspective view of the human heart showing thetypical positions of arteries and veins thereon.

FIG. 1 c is a longitudinal sectional view through an adjacent coronaryartery and coronary vein within segment 1 c of FIG. 1 a, wherein bloodflow passageways have been formed in accordance with the presentinvention to bypass an obstruction located within the coronary artery.

FIG. 1 d is a cross sectional view through line 1 d— 1 d of FIG. 1 c.

FIG. 1 e is a diagram of the Triangle of Brouck-Moscheau, an anatomical1 a landmark which is defined by certain coronary arteries and coronaryveins of the human heart, as visualized on an x-ray taken from the rightanterior oblique view.

FIG. 1 f is a perspective view of an alternative revascularizationmethod of the present invention wherein an extravascular interstitialpassageway is formed from a first location on a blood vessel (upstreamof an obstruction) to a second location on the same blood vessel(downstream of the obstruction).

FIG. 1 f is a perspective view of the blood vessel shown in FIG. 1 f,following complete application of the revascularization method of thepresent invention to form a bypass passageway around the obstruction.

FIG. 2 is a perspective view of a human body incorporating a schematicillustration of a transvascular method for performing a medicalprocedure at an extravascular location within the body, in accordancewith the present invention.

FIG. 2 a is an enlarged perspective view of the target tissue of FIG. 2,showing the manner in which a tissue-penetrating element is passed fromthe passageway-forming catheter into the target tissue.

FIG. 2 a is an enlarged view of the target tissue of FIG. 2 showing anaccess conduit which has been advanced through and/or exchanged into theextravascular passageway into the target tissue.

FIG. 2 b is a schematic showing of an indwelling delivery/samplingcannula having a subcutaneous injection port for repetitiveinfusion/withdrawal of matter into/from or monitoring of conditions inthe target area.

FIG. 2 c is a schematic showing of a catheter inserted through theextravascular passageway for temporarily deployment of a device into,monitoring of conditions in, or infusion/withdrawal of matter into/fromthe target area.

FIG. 2 d is a schematic showing of a permanently placed device (e.g.,fluid drainage shunt) utilizing the extravascular passageway of thepresent invention. FIG. 2 e is a schematic showing of a catheterinserted through the extravascular passageway of the present inventionand into the lumen of another tubular anatomical passageway, forsampling, access, monitoring, or performance of a surgical orinterventional procedure within the tubular anatomical passageway.

FIG. 2 f is a schematic showing of a transvascular procedure forperforming extravascular microsurgery, in accordance with the presentinvention.

FIG. 3 a is a longitudinal sectional view showing an unmodified bloodflow passageway formed in accordance with the present invention.

FIG. 3 b is a longitudinal sectional view showing an internally linedblood flow passageway formed in accordance with the present invention.

FIG. 3 c is a longitudinal sectional view showing a longitudinallycompressed blood flow passageway formed in accordance with the presentinvention.

FIG. 3 d is a longitudinal sectional view showing a blood flowpassageway of the present invention having a non-protrusive stent orstented graft positioned therewithin.

FIG. 3 d is a perspective view showing an optional flange and/oroptional projections which may be incorporated into a non-protrusivestent or stented graft positionable within a blood flow passageway ofthe present invention in accordance with FIG. 2 d.

FIG. 3 e is a sectional view through a blood flow passageway of thepresent invention, having a first embodiment of a hemiprotrusive orprotrusive stent or stented graft positioned therewithin.

FIG. 3 f is a sectional view through first and second blood flowpassageways of the present invention, having a second embodiment of aprotrusive stent or stented graft positioned therewithin.

FIG. 4 a is a schematic illustration of a first approach for formingarteriovenous blood flow passageways in accordance with the presentinvention.

FIG. 4 b is a schematic illustration of a second approach for formingarteriovenous blood flow passageways in accordance with the presentinvention.

FIG. 4 c is a schematic illustration of a third approach for formingarteriovenous blood flow passageways in accordance with the presentinvention.

FIG. 4 d is a schematic illustration of a fourth approach for formingarteriovenous blood flow passageways in accordance with the presentinvention.

FIG. 4 e is a schematic illustration of a fifth approach for forming anarteriovenous blood flow passageway in accordance with the presentinvention.

FIG. 5 a is a longitudinal sectional view of two (2) adjacent bloodvessels, illustrating a first means for orienting, aiming and guiding atissue-penetrating element to form an arteriovenous blood flowpassageway in accordance with the present invention.

FIG. 5 b is a longitudinal sectional view of an adjacent artery andvein, illustrating a second means for orienting, aiming and guiding atissue-penetrating element to form an arteriovenous blood flowpassageway in accordance with the present invention.

FIG. 5 c is a longitudinal sectional view of an adjacent artery andvein, illustrating a third means for orienting, aiming and guiding atissue-penetrating element to form an arteriovenous blood flowpassageway in accordance with the present invention.

FIG. 5 d is a longitudinal sectional view of an adjacent artery andvein, illustrating a fourth means for orienting, aiming and guiding atissue-penetrating element to form an arteriovenous blood flowpassageway in accordance with the present invention.

FIG. 5 e is schematic showing of a method for utilizing passiveradiographically visible markers to orient, aim and or guide atissue-penetrating element to form an extravascular passageway inaccordance with the present invention.

FIG. 5 e′ shows a first type of radiographic markers which may beutilized in accordance with FIG. 5 e.

FIG. 5 e″ shows a second type of radiographic markers which may beutilized in accordance with FIG. 5 e.

FIG. 5 e′″shows a third type of radiographic markers which may beutilized in accordance with FIG. 5 e. FIG. 5 f is a schematic showing ofa method for utilizing an ultrasonically visible marker to aim, alignand/or guide a tissue penetrating element to form an extravascularpassageway in accordance with the present invention.

FIG. 5 f′ is a perspective view of the ultrasonically visible markershown in FIG. 5 f.

FIG. 5 g is a schematic view of a method for using MRI to orient, aim orguide a tissue-penetrating element to form an extravascular passagewayin accordance with the present invention.

FIG. 5 g′ is a perspective view of a first embodiment of a markervisible by magnetic resonance imaging (MRI) to facilitate orientation,aiming and/or guidance of a tissue penetrating element to form anextravascular passageway in accordance with the present invention.

FIG. 5 g″ is a perspective view of a second embodiment of a markervisible by magnetic resonance imaging (MRI) to facilitate orientation,aiming and/or guidance of a tissue penetrating element to form anextravascular passageway in accordance with the present invention.

FIG. 5 h is a schematic showing of means for utilizing a dopplerapparatus to facilitate orientation, aiming and/or guidance of a tissuepenetrating element to form an extravascular passageway in accordancewith the present invention.

FIG. 5 i is a schematic showing of means for a pressure sensingapparatus to facilitate orientation, aiming and/or guidance of a tissuepenetrating element to form an extravascular passageway in accordancewith the present invention.

FIG. 5 j is a schematic showing of means for utilizing transmitter andreceiver apparatus for orienting, aiming and/or guiding a tissuepenetrating element to form an arteriovenous blood flow passageway inaccordance with the present invention.

FIG. 5 k is a schematic showing of means for utilizing transmitting andinduction coil apparatus for orienting, aiming and/or guiding a tissuepenetrating element to form an arteriovenous blood flow passageway inaccordance with the present invention.

FIG. 5 l is a schematic showing of means for utilizing magneticapparatus for orienting, aiming and/or guiding a tissue penetratingelement to form an arteriovenous blood flow passageway in accordancewith the present invention.

FIG. 6 a is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a first means for exiting of the tissue-penetrating element fromthe catheter.

FIG. 6 b is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a second means for exiting of the tissue-penetrating elementfrom the catheter.

FIG. 6 c is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a third means for exiting of the tissue-penetrating element fromthe catheter.

FIG. 6 d is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a fourth means for exiting of the tissue-penetrating elementfrom the catheter.

FIG. 6 d′ is a perspective view through of the distal end of thecatheter device shown in FIG. 6 d.

FIG. 6 e is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a fifth means for exiting of the tissue-penetrating element fromthe catheter.

FIG. 6 f is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a sixth means for exiting of the tissue-penetrating element fromthe catheter.

FIG. 6 g is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a seventh means for exiting of the tissue-penetrating elementfrom the catheter.

FIG. 6 h is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a eighth means for exiting of the tissue-penetrating elementfrom the catheter.

FIG. 6 i is a longitudinal sectional view of a portion of atransvascular tissue-penetrating catheter of the present invention,showing a ninth means for exiting of the tissue-penetrating element fromthe catheter.

FIG. 7 a is a longitudinal sectional view of a distal portion of thefirst embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 a′ is a cross sectional view through line 7 a′-7 a′ of FIG. 7 a.

FIG. 7 b is a longitudinal sectional view of a distal portion of thesecond embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 c is a longitudinal sectional view of a distal portion of thethird embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 d is a longitudinal sectional view of a distal portion of thefourth embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 d′ is a cross sectional view through line 7 d′-7 d′ of FIG. 7 d.

FIG. 7 e is a longitudinal sectional view of a distal portion of thefifth embodiment of a tissuepenetrating element in accordance with thepresent invention.

FIG. 7 e′ is a cross sectional view through line 7 e-7 e′ of FIG. 7 e.

FIG. 7 e′ is cross sectional view through an alternative embodiment ofthe device shown in FIG. 7 e, comprising a hollow tube having a solidstylet positioned therewithin.

FIG. 7 f is a longitudinal sectional view of a distal portion of thesixth embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 f′ is a perspective view of the trocar-tipped, elongate memberwhich forms a portion of the tissue-penetrating element shown in FIG. 7f.

FIG. 7 g is a longitudinal sectional view of a distal portion of theseventh embodiment of a tissue-penetrating element in accordance withthe present invention.

FIG. 7 h is a longitudinal sectional view of a distal portion of theeighth embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 i is a longitudinal sectional view of a distal portion of theninth embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 j is a longitudinal sectional view of a distal portion of thetenth embodiment of a tissue-penetrating element in accordance with thepresent invention.

FIG. 7 k is a longitudinal sectional view of a distal portion of theeleventh embodiment of a tissue-penetrating element in accordance withthe present invention.

FIG. 7 l is a longitudinal sectional view of a distal portion of thetwelfth embodiment of a tissue-penetrating element in accordance withthe present invention.

FIG. 7 m is a longitudinal sectional view of a distal portion of thethirteenth embodiment of a tissue-penetrating element in accordance withthe present invention.

FIG. 8 a is a longitudinal sectional view of a first embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 b is a longitudinal sectional view of a second embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 c is a longitudinal sectional view of a third embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 d is a longitudinal sectional view of a fourth embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 e is a longitudinal sectional view of a fifth embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 f is a longitudinal sectional view of a sixth embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 g is a longitudinal sectional view of a seventh embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 h is a longitudinal sectional view of a eighth embodiment of anapparatus for modifying an interstitial passageway formed in accordancewith the present invention.

FIG. 8 h′ is an elevational view of the device of FIG. 8 h being used tomodify and arteriovenous blood flow passageway formed in accordance withthe present invention.

FIG. 9 a is an elevational view of a first embodiment of a device usableto longitudinally compress an arteriovenous passageway formed inaccordance with the present invention.

FIG. 9 a′ is an exploded perspective view of the device shown in FIG. 9a.

FIG. 9 b is an elevational view of a second embodiment of a deviceusable to longitudinally compress an arteriovenous blood flow passagewayin accordance with the present invention.

FIG. 9 b′ is a partial longitudinal sectional view of the device of FIG.9 b mounted within a delivery catheter.

FIG. 9 b″ is a perspective view of the device of FIG. 9 b partiallyejected from its delivery catheter.

FIG. 9 b′″ is a perspective view of the device of FIG. 9 b fully ejectedfrom its delivery catheter.

FIG. 9 c is an elevational view of a third embodiment of a device usableto longitudinally compress an arteriovenous blood flow passageway inaccordance with the present invention.

FIG. 9 d is an elevational view of a fourth embodiment of a deviceusable to longitudinally compress an arteriovenous blood flow passagewayin accordance with the present invention.

FIG. 9 e is an elevational view of a fifth embodiment of a device usableto longitudinally compress an arteriovenous blood flow passageway inaccordance with the present invention.

FIG. 9 f is an elevational view of a sixth embodiment of a device usableto longitudinally compress an arteriovenous blood flow passageway inaccordance with the present invention.

FIG. 9 f′ is a partial longitudinal sectional view of the device of FIG.9 f mounted within a delivery catheter.

FIG. 9 f″ is a perspective view of the device of FIG. 9 f as it ismounted within its delivery catheter.

FIG. 9 f′″ is a longitudinal sectional view of the device of FIG. 9 f″″partially deployed out of its delivery catheter.

FIG. 9 f″″ is a cross sectional view of the device of FIG. 9 f fullydeployed out of its delivery catheter.

FIG. 10 a is a perspective view of a first embodiment of a transvasculartissue-penetrating catheter device of the present invention.

FIG. 10 b is a longitudinal sectional view through line 10 b- 10 b ofFIG. 10.

FIG. 10 c is a longitudinal sectional view through line 10 c of FIG. 10a.

FIG. 10 d is a cross sectional view through line 10 d-10 d of FIG. 10 a.

FIG. 10 c′ is a schematic view of an optional guide wire/sheath urgingapparatus which may be incorporated into any embodiment of thetransvascular tissue-penetrating catheter of the present invention.

FIG. 10 c″ is a schematic showing of the apparatus of FIG. 10 c as thetissue-penetrating element of the catheter device is penetrating throughtissue.

FIG. 10 c″ is a schematic showing of the device of FIG. 10 c′″ after thetissue-penetrating element has penetrated through tissue and into avascular lumen or open cavity.

FIG. 11 a is a longitudinal section view through the handpiece componentof a second embodiment of a transvascular tissue-penetrating catheterdevice of the present invention.

FIG. 11 b is a partial longitudinal sectional view through a distalportion of the second embodiment of the transvascular tissue-penetratingcatheter device of the present invention during a first stage of atissue-penetrating procedure.

FIG. 11 c is a longitudinal section showing of the device of FIG. 11 bduring a second stage of a tissue-penetrating procedure.

FIG. 11 d is an enlarged longitudinal sectional view of segment lid ofFIG. 11 c.

FIGS. 12 a-12 d is a step-by-step illustration of the first embodimentof the tissue penetrating catheter device and system 100 p shown inFIGS. 10-10 c′″ within a body lumen.

FIGS. 13 a-13 e is a step-by-step illustration of the second embodimentof the passageway forming catheter device and system 100 p′ with a bodylumen.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description and the drawings to which it refersare provided for the purpose of describing certain presently preferredembodiments of the present invention only, and are not intended to limitthe scope of the invention in any way. Indeed, it is to be appreciatedthat the detailed descriptions and examples set forth herebelow areprovided as mere examples or illustrations of certain ways in which theinvention may be utilized or practiced. These examples and illustrationsare not intended to provide an exhaustive description of all possibleembodiments and examples of the invention but, rather, are illustrativeof some but not all applications to which the invention may be applied.

A. The Methods of the Present Invention

i. Revascularization Methods

Broadly stated, the revascularization method of the present inventionprovides a method for establishing one or more passageway(s) 10 throughwhich blood may flow from or into at least one blood vessel. In mostcases, the blood which flows through the passageway will preferably havea pO₂ in excess of about 50.

In some instances the extravascular passageway(s) 10 will be used forbypassing an obstructed, injured or disease-affected segment of anartery. In some embodiments of the invention, only a primary blood flowpassageway (e.g., a passageway from the artery upstream of theobstruction) will be formed between an obstructed, injured ordisease-affected artery (or another unimpaired artery a blood-filledanatomical structure such as a chamber of the heart), and a vein,thereby permitting arterial blood to flow in the retrograde directionthrough the vein, so as to retroperfuse tissues through the venousvasculature. In other embodiments of the invention, one or moresecondary blood flow passageway will also be formed between theobstructed artery and the vein, downstream of the obstruction, such thatarterial blood which has entered the lumen of the vein through theprimary blood flow (passageway(s) may subsequently enter or re-enter thelumen of the artery, downstream of the obstruction, thereby perfusingtissues through the remaining (e.g., unobstructed) portion of theobstructed artery.

Although the anatomical showings provided in FIGS. 1 a and 1 b arespecific to the coronary vasculature, it is to be appreciated that themethods of the present invention may be applied to blood vesselsthroughout the body and are not necessarily limited the treatment ofobstructed coronary arteries (e.g., the femoral-popliteal region,aorta-iliac region, etc.).

With reference to the drawings, FIGS. 1 a and 1 b provide detailedshowings of the normal vascular anatomy of a human heart whereincoronary arteries are substantially parallel and adjacent to coronaryveins. The specific anatomical structures shown in FIGS. 1 a, 1 b and 1e are labeled in accordance with the following legend:

A . . . Aorta

AIV . . . Anterior Interventricular Vein

CA . . . Coronary Artery

CV . . . Coronary Vein

CS . . . Coronary Sinus

CIR . . . Circumflex Artery

IVC . . . Inferior Vena Cava

LAD . . . Left Anterior Descending Artery

SVC . . . Superior Vena Cava

PA . . . Pulmonary Artery

PV . . . Pulmonary Vein

TA . . . Tunica Adventitia

TM . . . Tunica Media

TI . . . Tunica Intima

GCV . . . Great Cardiac Vein

FIGS. 1 c- 1 d illustrate a specific application of the presentinvention, wherein an obstruction OB is located within a coronary arterylocated on the left anterior aspect of the heart. As shown, theobstructed coronary artery CA is located adjacent, and generallyparallel to, a coronary vein CV. A first blood flow passageway 10 a isformed between the coronary artery CA and the adjacent coronary vein CV,at a location upstream of the arterial obstruction OB. Also, in theshowing of FIG. 1 c, an optional second blood flow passageway 10 b hasbeen formed between the lumen of the coronary vein CV and the lumen ofthe coronary artery CA, at a location downstream of the obstruction OB.Also, in these figures, optional embolization members 12 a, 12 b areshown to have been placed within the lumen of the coronary vein CV atsites proximal of the first blood flow passageway 10 a, and distal ofthe optional second blood flow passageway lob. These optionalembolization member serve to guide the flow of arterial blood whichenters the coronary artery CA through the first blood flow passageway 10a, through a segment of the adjacent coronary vein CV, and through thesecond blood flow passageway 10 b such that the arterial blood reentersthe lumen of the coronary artery CA, downstream of the obstruction OB.Optional embolization members 12 a, 12 b may be any one or combinationof devices sufficient to block or impede flow such as coils; hemostaticmaterials such as collagen, Gelfoam™ or fibrin, covered stents orframes, detachable balloons, valve structures clips, fasteners or plugs,etc. Further, the function served by these members may also beaccomplished utilizing various methods including ligation, welding,coagulation, or other surgical methods.

As illustrated in the cross sectional showing of FIG. 1 d, each bloodflow passageway 10 of the present invention is essentially aninterstitial tunnel which extends through the wall of an artery (such asa coronary artery CA) through the wall of an adjacent vein (such as acoronary vein CV) and through any connective or membranous tissue whichmay be located between the coronary artery CA and coronary vein CV. Inthis manner, each blood flow passageway 10 acts as a flow conduitbetween the lumens of the coronary artery CA and coronary vein CV.

FIG. 1 e is a diagram of a portion of the coronary vasculature known asthe Triangle of Brouck-Moscheau. The Triangle of Brouck-Moscheau isdefined by the left anterior descending coronary artery LAD, thecircumflex coronary artery CIR, the anterior interventricular vein AIVand the great cardiac vein, GCV, as shown. Obstructions resulting fromthe build-up of atherosclerotic pla que are often found in the proximalportions of the left anterior descending artery LAD and/or thecircumflex artery CIR. The revascularization methods of the presentinvention may be utilized to treat such obstructions of the leftanterior descending artery LAD and/or circumflex artery CIR by formingappropriate blood flow passageways 10 between the arteries and veinssurrounding the Triangle of Bouck-Moscheau. For example, if anobstruction is present in the proximal portion of the left anteriordescending artery LAD, a first blood flow passageway loa may be formedbetween the great cardiac vein GCV and the circumflex artery CIR and asecond blood flow passageway 10 b may be formed between the leftanterior descending artery LAD and the anterior intraventricular arteryAIV, at a location downstream of the obstruction. A lumen blockingmember 12 may be placed within the great cardiac vein GCV, proximal tothe first blood flow passageway 10 a and/or within the anteriorinterventricular vein AIV distal to the second blood flow passageway 10b such that arterial blood from the circumflex artery CIR will flowthrough the first blood flow passageway 10 a, through the great cardiacvein GCV, through the anterior interventricular vein AIV and into theleft anterior descending artery LAD, downstream of the obstruction.Alternatively, in cases where the obstruction is present in thecircumflex artery CIR, the first blood flow passageway 10 a and secondblood flow passageway 10 b may be inverted, such that blood flowingthrough the left anterior descending artery LAD will flow through theanterior interventricular vein AIV, through the great cardiac vein GCVand into the circumflex artery CIR, downstream of the obstruction. Inaccordance with these examples, it will be appreciated that therevascularization method of the present invention may be utilized in amanner which obtains arterial blood from an artery or from any othersource (e.g., left ventricle), and passes such arterial blood intoanother artery. Moreover, in accordance with the revascularizationmethods of the present invention, it will be appreciated that the secondblood flow passageway 10 b may, in at least some cases, be eliminatedand arterial blood may be provided to the blood-deprived regions of themyocardium by retroprofusion through the anterior interventricular veinAIV or great cardiac vein GCV.

It will be appreciated that in some applications of therevascularization method of the present invention, the extravascularpassageway 10 may comprise an interstitial tunnel which extends from afirst location to a second location, on the same blood vessel. As shownin FIG. 1 f, a blood vessel BV having an obstruction OB formed thereinmay be bypassed by utilizing a passagewayforming catheter 100 of thepresent invention whereby a tissue-penetrating element 102 is passedthrough the wall of the blood vessel upstream of the obstruction,through the adjacent tissue, and subsequently through the wall of theblood vessel downstream of the obstruction. In this manner, aninterstitial passageway 10, shown in FIG. 1 f′, forms a bypass conduitaround the obstruction OB in the blood vessel BV.

ii. Methods for Performing Surgical or Interventional Procedures atExtravascular Locations

In addition to the above-described revascularization methods, thepresent invention also includes methods for performing various surgicalor interventional procedures at extravascular locations within the body.These methods of the present invention are accomplished by forming oneor more extravascular passageways from a blood vessel to anextravascular location (e.g., organ, tissue, body cavity, etc.) andsubsequently passing one or more procedure-performing apparatus throughthe extravascular passageway to accomplish the desired surgical orinterventional procedure at the extravascular location. The types ofsurgical or interventional procedures which may be performed inaccordance with this method of the present invention include:

Delivery of Therapeutic Matter

Delivery of flowable drug substance;

Implantation of an implantable drug delivery apparatus (e.g.,microspheres, etc.);

Delivery of medical treatment fluids;

Implantation of access catheter for ongoing drug dosing;

Implantation of genetic material, cells, microbial or viral vectors,etc.

Temporary or Permanent Deployment of Device(s)

Implantation of stimula tor (electrical or physical);

Implantation of sensor;

Implantation of electrode;

Implantation of transmitter, receiver or transponder;

Implantation of support member (e.g., stent);

Implantation of marker (e.g., radiographically visible markers, orsolutions.

Tissue Resection, Excision or Ablation

Tissue ablation or destruction;

Cutting or transection of tissue (e.g., nerve, fibers);

Resection and removal of neoplasms, diseased tissue, etc.;

Dilation, stretching or other modification of endogenous tissue torestore patency, flow, configuration, or function.

Sampling Applications

Sampling of tissue (e.g., biopsy);

Sampling of solid matter (e.g., calculus, tophi, etc.);

Monitoring Applications

Determining pressure, pH, temperature, oxygen saturation, partialpressure of dissolved gas, ECG, EEG, evoked potentials, or othervariables which are measurable at the target area.

FIGS. 2-2 f are provided for the purpose of further describing andillustrating some of the specific interventional and/or surgicalprocedures which may be performed in accordance with this embodiment ofthe present invention. FIG. 2 shows a schematic illustration of thehuman body wherein a passageway-forming catheter apparatus 100 of thepresent invention has been percutaneously inserted into a blood vessel(e.g., femoral vein) and has been advanced through the vena cava,internal jugular vein and great cerebral vein, to a desired locationadjacent the extravascular target area (e.g., ventricle of the brain).Thereafter, a tissue-penetrating element 102 is passed from the catheter100 through the wall of cerebral blood vessel wherein the distal portionof the catheter 100 is located and the tissue penetrating element isadvanced through the adjacent brain tissue to an extravascular targetlocation T within the brain. In this manner, an extravascular passageway10 has been formed from the cerebral blood vessel to the extravasculartarget location T. As necessary, the passageway 10 which is initiallyformed by the tissue-penetrating element 102 may be debulked, enlargedor modified in accordance with the apparatus and methods for passagewaymodification shown in FIGS. 8 a-8 h and described in detail herebelow.

FIG. 2 a is an enlarged view of the target area T and the adjacent bloodvessel BV into which the passageway-forming catheter device 100 has beenadvanced. Initially, the tissue-penetrating element 102 of thepassageway-forming catheter device 100 is advanced out of the catheter100, through the wall of the blood vessel BV, and through tissue whichis located between the blood vessel BV and the target area T. Thetissue-penetrating element 102 utilized in this application preferablyincorporates a lumen 114 through which a secondary guide wire GW₂ may beadvanced into the target area T. Thereafter, the tissue-penetratingelement 102 may be retracted and removed along with thepassageway-forming catheter 100, leaving the secondary guide wire GW₂ inplace.

As shown in FIG. 2 a, an access canula 103 may then be advanced over thepre-positioned secondary guide wire GW₂ such that the cannula 103extends through the vasculature, through the extravascular passageway 10formed by the tissue-penetrating element 102 and into the target area T.This access cannula may then be utilized as a conduit for introductionof drugs, impla ntation of devices, sampling, monitoring, deployment ofsurgical apparatus or other applications in accordance with the methodsfor performing surgical or interventional procedures at extravascularlocations, described hereabove.

FIGS. 2 b-2 f illustrate specific examples of the types of extravascularsurgical or interventional procedures which may be performed inaccordance with this aspect of the invention.

With reference to FIG. 2 b, a subcutaneous port apparatus 105 may bemounted on the proximal end of the access cannula 103, and may beutilized for the injection or withdrawal of flowable substances (e.g.,drugs, medical treatment fluids, radiographic contrast solutions, cells,genetic material, microbial or viral vectors, etc.) through the accesscannula 103, and into the target area T. Also, the port apparatus 105and cannula 103 may be utilized to accomplish periodic monitoring ofpressure or other conditions at the target area T (e.g., by filling thecannula 103 with fluid and inserting a needle connected to a pressuretransducer into the port apparatus 105, a reading of pressure at thetarget area T may be obtained). Thus, FIG. 2 b illustrates the manner inwhich an indwelling access cannula 103 having a subcutaneouslypositioned injection port 105 may be utilized for continuing infusion orwithdrawal of flowable matter into/from the target area T. Specificexamples of the types of conditions which may be treated by repeatedinfusions of drugs to a specific target area T within the body includeParkinsons disease, epilepsy, hypertension, tumors, depression,Alzheimer's disease, sleep disorders, behavior disorders, motordysfunctions, etc. Additionally, the access cannula 103 and injectionport 105 may be used as a means for periodically infusing repla cementfluids or solutions, to effect various types of replacement therapies.These applications may also be performed with the device shown in FIG. 2c.

FIG. 2 c shows an alternative arrangement wherein the access cannula 103is exteriorized and is utilized as a conduit for the passage of atemporary device 106 into the target area T. The device 106 may beconnected to an extracorporeal apparatus 107 which will deliver someform of energy to the device 106, or will receive information from thedevice 106. Examples of the types of extracorporeal apparatus 107 whichmay be utilized include, but are not necessarily limited to, electricalsignal generators, electrocautery apparatus, radio frequency signalgenerators, cryogenic apparatus, ultrasound generators, form ofoscilloscopes, monitors, chart recorders, galvanometers, laser, scopes,other instrumentation, etc. Specific examples of the types of treatmentswhich may be delivered to the target area T by way of a temporarilypositioned device 106 include radio frequency ablation of tissue (e.g.,nerve tracts or arythmogenic tracts within the heart) cryogenic tissuedestruction (e.g., of a tumor), electrocautery (e.g., to stop ahemorrhage or abla te tissue), etc. Examples of the types of monitoringor information retrieval operations which may utilized in connectionwith a temporarily-positioned device 106 include localized EEGmeasurements, localized ECG measurements. Recordation of galvanometricresponses, oxygen saturation measurements, partial pressure measurementsof gasses dissolved in fluids, pH measurements, electrode determinationsof the concentrations of specific electrolytes or other chemicalsubstances, etc.

FIG. 2 d shows an application of the present invention wherein theaccess cannula 103 is utilized to continually drain fluid from thetarget area T. In this manner, the proximal portion of the accesscannula 103 is provided with a plurality of outlet apertures 109 suchthat excess fluid which collects within the target area T will drainproximally through the lumen of the access cannula 103 and out of outletapertures 109. The proximal portion of the access cannula 103 having theoutlet apertures 109 formed therein may be exteriorized such that excessfluid is drained into an extracorporeally located container or vessel,or alternatively be impla nted at another location within the body(e.g., the peritoneal cavity) such that excess fluid will pass into suchother area of the body where it can be assimila ted by naturalphysiologic functions without causing damage or harm to the body. Oneexample of such application is the use of the cannula 103 as anindwelling shunt or draining excess cerebrospinal fluid from a ventricleof the brain to a secondary location (e.g., peritoneum) within the body.Because the cannula 103 has been impla nted through the vascula ture andthrough the extravascular passageway 10 created in accordance with theinvention, the technique used for implantation of the cannula 103 may beperformed percutaneously without requiring large surgical incisions asmay be typical of other methods utilized to implant fluid-drainage shuntdevices used for the treatment of hydrocephalus and other disorders.

FIG. 2 e shows another specific application of the present invention,wherein the access cannula 103 extends from the blood vessel BV, throughthe extravascular passageway 10 of the present invention and into thelumen 111 of a secondary tubular anatomical passageway or duct which isthe target T in this application. The types of tubular passageways orducts which may form the target T in this application of the inventioninclude blood vessels, geneto-urinary ducts, exocrine ducts, endocrineducts and lymph ducts. After the access cannula 103 has been positionedwithin the lumen 111 of the target duct or passageway T, any of theabove-listed applications for this methodology may be utilized includingwithdrawal of samples of infusion of drugs, deployment of devices, etc.

FIG. 2 f illustrates yet another specific example of an application ofthe invention wherein the access cannula 103 extends through the vasculature, through an extravascular passageway 10 of the present invention,and into a target area T such that one or more surgical instruments 113may be passed into the target area T for the purpose of performing asurgical (e.g., microsurgical) procedure within the target area T. Inthis manner, an exteriorized control system 115 may be connected to thesurgical instrument(s) 113 and may be utilized to effect the desiredoperation and manipula tion of the surgical instrument 113 within thetarget area T.

iii. Types of Passageways

FIGS. 3 a-3 f, and the detailed description set forth herebelow,describe certain types of extravascular passageways 10 which may beformed in accordance with the present invention. The showings of FIGS. 3a-3 f and the following detailed description are presented as mereexamples of types of passageways which may be formed, and are notintended to exhaustively describe all possible types of passageways 10which may be utilized in accordance with the present invention.Furthermore, it is to be noted that although the showings of FIGS. 3 a-3f are directed to passageways 10 formed between a vein and artery, thevarious passageway modifications illustrated in FIGS. 3 a-3 f arebroadly applicable to any or all types of extravascular passageways 10formed in accordance with the present invention, for which suchmodifications may be suitable. Indeed, the passageways 10 shown in FIGS.3 a-3 f and described herebelow are not limited to passageways formedbetween arteries and veins, but may be broadly applicable to allpassageways 10 of the present invention.

As shown in FIGS. 3 a, the passageways 10 of the present invention maycomprise unstented, unlined, interstitial tunnels (FIG. 3 a).Alternatively, as shown in FIGS. 3 b-3 f, such passageways 10 may beprovided with various types of surface modifications or ancillaryapparatus, such as tubular linings (FIG. 3 b), longitudinal constrainingclips (FIG. 3 c), stents or stented grafts which are confined to theinterior of the passageway 10 (FIG. 3 d), or stents or stented graftswhich protrude out of and beyond the passageway 10 (FIGS. 3 e-3 f).

Referring specifically to FIG. 3 a, there is shown a passageway 10 whichextends between two blood vessels and which is devoid of any stent,liner, tubing, coating, valve, surface modification, substance orapparatus disposed within the passageway 10. In this regard, thisunstented, unlined, unmodified passageway 10 is simply an interstitialtunnel (e.g., a puncture tract or tunnel) which extends between twoblood vessels such that blood may flow from the lumen of one bloodvessel into the lumen of the other.

FIG. 3 b shows a passageway 10 formed between two blood vessels andhaving a tubular inner lining 20 disposed therewithin. Such inner lining20 may comprise a segment of rigid or flexible plastic tubing, a layerof a biocompatable polymeric coating, layer of cells of a type whichdiffers from that of the surrounding tissue (e.g., endothelial 1 a yerbiological tissue graft, etc.), a layer of tissue of modified density asmay be formed by laser treatment, electrocautery, etc., or any othertype of matter which differs from the inner surface of the unstented andunlined passageway 10 itself. Such lining within the passageway 10 mayserve to a) facilitate laminar and non-turbulent blood flow through thepassageway 10 or b) prevent unwanted closure of the passageway due tonatural contraction of surrounding muscle or tissue ingrowth into thepassageway 10. In instances wherein the lining 20 is formed byapplication of a flowable material or energy (e.g., a chemical substanceto produce a controlled chemical burn of the tissue or a biocompatablepolymer coating, a suspension of endothelial cells, etc. . . ) to thewalls of the passageway 10, the application of such flowable material tothe wall(s) of the passageway 10 may be accomplished through the use ofa device such as that shown in FIGS. 8 h-8 h″ and discussed more fullyherebelow, in reference to the devices of the present invention.

FIG. 3 c shows a passageway 10 wherein a longitudinal constrainingapparatus 22 has been positioned so as to longitudinally compress theopposite ends of the passageway 10 toward one another, therebycompacting any tissue (e.g., loose connective tissue) which is locatedbetween the blood vessels. Such longitudinal constraining apparatus 22may also be constructed to provide radial support for, and/or maintainpatency of the passageway 10. The application of longitudinalcompression to the passageway 10 by a constraining apparatus 22 may beparticularly important in applications of the invention wherein theblood vessels which the passageway 10 connects are located on thesurface of an organ (e.g., epicardially located coronary artery andvein), or are otherwise located such that cavernous or loose tissue(e.g., loose connective tissue) or open space exists between the arteryand vein. The presence of such cavernous or loose tissue may allow bloodwhich flows through the passageway 10 to infiltrate into such tissue orspace between the artery and vein, as may result in the formation of ahematoma. Examples of specific types of constraining apparatus 22 whichmay be utilized to longitudinally compress the blood flow passageway 10as shown in FIG. 2 c, or to otherwise facilitate coupling of two bloodvessels by side-to-side anastomosis, are shown in FIGS. 9 a-9 f, and aredescribed more fully herebelow with reference to FIGS. 9 a-9 f.

FIG. 3 d shows a passageway 10 of the present invention having anon-protrusive stent or stented graft 24 positioned within thepassageway 10. Such stent or stented graft 24 may comprise apressure-expandable or self-expanding cylindrical stent or frame work,and may optionally be covered by a continuous tubular member such as apliable segment of woven polyester or expanded polytetrafluoroethylene(ePTFE) the disposition of such stent or stented graft 24 within thepassageway 10 may serve to hold the passageway 10 in a substantiallyopen configuration to facilitate non-turbulent blood flow through thepassageway 10. The stent or stented graft 24 may be formed of anysuitable material including, but not necessarily limited to, varioustypes of pressure expandable or self-expanding wire mesh or interwovenstrands of polymeric material. In instances where a stented graft 24 isutilized, the tubular graft covering on the stented graft 24 may becontinuous or may be partial, such that only a portion of the stent iscovered.

It will be appreciated that when a protrusive stented graft (e.g.,covered stent 26 or 28) is utilized, it may be unnecessary toadditionally position the optional embolization members 12 within thelumen of the blood vessel into which the stented graft 26, 28 extend, asthe tubular outer covering on the stented graft will serve to define aclosed flow conduit through the lumen of that blood vessel and willsubstantially block the flow of endogenous blood through that portion ofthe blood vessel, thereby obviating any need for separate embolizationmembers 12.

FIG. 3 d′ shows modifications of the stent or stented graft 24 a toinclude a flange 25 and/or perpendicular projections 27 extending fromone or both end(s) of the stent or stented graft 24 a to hold the stentor stented graft 24 a in substantially fixed longitudinal positionwithin the passageway 10.

FIG. 3 e shows a hemiprotrusive or protrusive stent or stented graft 26which may be constructed in the same manner as the non-protrusive stentor stented graft 24 shown in FIG. 3 d, but which differs from that shownin FIG. 3 d in that it protrudes or extends beyond the ends of thepassageway 10, into adjacent portions of the artery A and vein. When sodeployed, this stent or stented graft 26 will generally assume an “S”configuration, as shown in FIG. 3 e, to facilitate laminar,non-turbulent flow of blood in the desired direction through thepassageway 10. The dotted lines on FIG. 3 e illustrate a“hemiprotrusive” embodiment of the stent or stented graft 26 wherein oneend thereof is flush with one end of the passageway 10, while the otherend thereof extends into the anatomical structure (i.e., vein) adjacentthat end of the passageway 10. Such “hemiprotrusive” embodiment of thestent or stented graft 26 may be employed so as not to obstruct anyavaila ble blood flow through the artery A, and will be particularlyapplicable in patients in whom the obstruction OB is not complete, andin whom some arterial blood flow continues to pass through the artery A.In other patients wherein the obstruction OB is complete, it may beappropriate to use the full “protrusive” embodiment of the stent orstented graft 26 wherein such stent or stented graft 26 extends out ofboth ends of the passageway 10 into the adjacent anatomical structures(i.e., vein and artery), as indicated by the dotted lines on FIG. 3 e.

FIG. 3 f shows another protrusive stent or stented graft 28 whichextends fully through a first blood flow passageway 10 a and an optionalsecond blood flow passageway 10 b, and which additionally protrudesthrough adjacent portions of the artery A and vein V, thereby forming acontinuous “U”-shaped conduit through which laminar, non-turbulent bloodflow may pass through both passageways 10 a, 10 b.

It will be appreciated that one or more valves may also be formed withinany embodiment of the stent or stented graft 24, 26, 28 or within atubular lining 20, or within a longitudinal constraining apparatus 22,or otherwise within the passageway 10, to facilitate the flow of bloodin a desired direction(s) through the passageway(s) 10 while deterringor preventing blood from backflowing through the passageway(s) 10 indirection(s) opposite the desired direction(s).

iv. Transvascular Approaches for Forming the Passageway(s) Between TwoBlood Vessels

FIGS. 4 a-4 e and the following detailed description, are provided forthe purpose of illustrating some approaches which may be utilized forforming extravascular passageways 10 between two blood vessels, toaccomplish certain revascularization methods of the present invention.The showings of FIGS. 4 a-4 e and the following detailed description arenot intended to exhaustively illustrate all possible approaches whichmay be utilized for forming such passageways 10, but rather are providedas mere examples of presently perceived approaches for such procedures.Furthermore, although the showings of FIGS. 4 a-4 e illustrateapplications wherein an obstruction OB is present within one of theblood vessels, the general approach is illustrated in these figures maybe applicable to various revascularization methods wherein thepassageways 10 are formed for purposes other than bypassingobstructions, or wherein the obstructions OB are located remotely fromthe locations at which the passageway(s) 10 are formed. Furthermore, itis to be appreciated that the approach is illustrated in FIGS. 4 a-4 cneed not necessarily be performed between two blood vessels or betweenan artery and vein. Indeed, these approaches may be applicable betweenany blood vessel and any other hollow anatomical structure, and may beuseable for vein to vein, artery to artery or vein to arterypassageway(s) 10.

FIG. 4 a shows one type of approach wherein a catheter 100 is advancedtransluminally into an artery A and a tissue-penetrating element 102 ispassed from the catheter 100 to form a first passageway 10 a through thewall of the artery A, through a tissue located between the artery A andvein V, and through the wall of the vein. After the first blood flowpassageway 10 a has been created in this manner, a guide wire may bepassed through the tissue-penetrating element 102 or through thecatheter 100, and through the newly-created first passageway 10 a.Thereafter, the tissue penetrating element is deactivated (e.g.,retracted into the catheter 100), and the catheter is advanced over theguide wire, through the first passageway 10 a, and into the lumen of thevein, past the site of the obstruction OB in the adjacent artery A.Thereafter, with the distal portion of the catheter positioned withinthe lumen of the vein, the tissue penetrating element 102 is once againadvanced out of the catheter 100 to form a second blood flow passageway102 which extends through the wall of the vein, any tissue locatedbetween the vein and artery A, and through the wall of the artery A.Thereafter, the tissue penetrating element 102 may be once againretracted into the catheter 100 and the catheter may be retracted fromthe vascula ture and out of the body. In this manner, the approach shownin FIG. 4 a, accomplishes formation of a first blood flow passageway 10a upstream of the arterial obstruction OB and a second blood flowpassageway 10 b downstream of the arterial obstruction.

FIG. 4 b shows an alternative approach wherein a catheter 100 istransluminally advanced into the lumen of a vein, and the distal end ofthe catheter is positioned adjacent the location at which the firstblood flow passageway 10 a is to be created. Thereafter, the tissuepenetrating element 102 is passed out of the catheter 100 to form thefirst blood flow passageway 10 a through the wall of vein V, any tissuebetween the vein V and artery A, and through the wall of the artery A.Thereafter, the tissue penetrating element 102 is deactivated (e.g.,retracted into the catheter 100), and the catheter is advanced furtherthrough the vein V until the distal end of the catheter is locatedadjacent the location at which the second blood flow passageway 10 b isto be created. Thereafter the tissue penetrating element 102 is onceagain passed out of the catheter 100, to form the desired secondpassageway 10 b through the wall of the vein V, and tissue between thevein V and artery A, and through the wall of the artery A. Thereafter,the tissue penetrating element 102 is once again deactivated (e.g.,retracted into the catheter 100) and the catheter 100 may be extractedfrom the venous vascula ture and removed. In this manner, the approachdepicted in FIG. 4 b accomplishes the formation of a first blood flowpassageway 10 a downstream of the arterial obstruction OB and a secondblood flow passageway 10 b upstream of the arterial obstruction OB, bycannulation and transluminal catheterization of the vein V only.

FIG. 4 c shows another alternative approach wherein a catheter 100 istransluminally advanced into an artery A, and the distal end of thecatheter 100 is positioned adjacent the site at which the first bloodflow passageway 10 a is to be formed. Thereafter, the tissue-penetratingelement 102 is passed out of the catheter 100 to form the first bloodflow passageway 10 a through the wall of the artery, any tissue betweenthe artery A and vein V, and through the wall of the vein V. Thereafter,the tissue penetrating element 102 is deactivated (e.g., retracted intothe catheter 100) and the catheter is further advanced through the lumenof the artery A and is passed through the obstruction OB until thedistal end of the catheter 100 is located adjacent the site at which thesecond blood flow passageway 10 b is to be formed. Such advancement ofthe catheter 100 through the obstruction OB will typically require thata guide wire be initially advanced through the obstruction OB tofacilitate subsequent advancement of the catheter 100 through theobstruction OB. Such initial passage of a guide wire through theobstruction OB may be accomplished in cases where the obstruction OB ispartial, or where the obstructive material is soft enough to permit aguide wire to penetrate therethrough. However, in cases where theobstruction OB is complete or formed of calcified plaque or other hardmatter, the approach shown in FIG. 4 c may be less than viable and theoperator will typically opt for one of the approaches shown in FIGS. 4 aor 4 b in such cases. However, in cases where the catheter 100 has beensuccessfully advanced through the obstruction OB as shown in FIG. 4 c,the tissue penetrating element 102 will then be once again advanced outof the catheter 100 to create the second blood flow passageway 10 bthrough the wall of the artery 10 a, any tissue between the artery A andvein V, and through the wall of the vein V. Thereafter, thetissue-penetrating element 102 will be deactivated (e.g., retracted intothe catheter 100) and the catheter will be extracted from the arterialvascula ture and removed from the body. In this manner, the approachshown in FIG. 4 c accomplishes formation of a first blood flowpassageway 10 a and second blood flow passageway 10 b in accordance withthe present invention.

FIG. 4 d shows another alternative approach wherein a catheter 100 isprovided with a positive pressure pumping 104 for pumping positivepressure fluid (e.g., saline solution) through the catheter and out of aplurality of positive pressure outlet apertures 106 formed in the bodyof the catheter 100 near the distal end thereof. A proximal sealingmember 108 (e.g., a balloon which completely blocks the blood vessellumen) is formed on the catheter, proximal to the positive pressureoutlet apertures 106. A separate distal sealing (e.g., a balloon) 110 isplaced within the lumen of the vein V, slightly upstream of the sitewhere the second blood flow passageway 10 b is to be created. Thecatheter 100 is advanced through the lumen of the vein V until thedistal end of the catheter is positioned adjacent the site of at whichthe second blood flow passageway 10 b is to be created. Thereafter, theproximal sealing member 108 is deployed (e.g., inflated) so as tocompletely seal the vein V proximal to the positive pressure outletapertures 106 of the catheter 100. Thereafter, positive pressure fluid(e.g., saline solution) is passed through a lumen of the catheter andout of the positive pressure outlet apertures 106, to cause the pressureP₁ within the vein V to become elevated and, preferably, substantiallyequal to the mean pressure P₂ within the artery A. Such pressurizationof the lumen of the vein V provides a viable method of identifying thepresence of any venous side branches SB which may require ligation,closure or embolization so as to prevent any significant steal of bloodfrom the newly-created venous bypass conduit. Additionally, suchpressurization of a lumen of the vein V may be maintained while thetissue-penetrating element 102 is advanced out of the catheter 100,through the wall of the vein V and through the wall of the artery A toform the passageway 10 of the present invention. Such equalization ofthe pressure P1 within the vein V to the pressure P₂ within the arteryalso serves to prevent any rapid gush or flow of blood from the lumen ofthe artery A into the lumen of the vein v when the passageway 10 iscreated.

FIG. 4 e shows another alternative approach wherein a first catheter 100is advanced into the artery A, and a second catheter 100 is advancedinto the vein V. In some instances, the first and second catheters 100will be advanced in generally opposite directions, as shown in FIG. 4 e.Thereafter, the tissue-penetrating elements 102 of the respectivecatheters 100 are utilized to form first and second blood flowpassageways 10 a, 10 b between the artery A and vein V, as shown.Thereafter, the tissue-penetrating elements 102 will be deactivated(e.g, retracted into the catheters 100) and the catheters 100 will beextracted from the vascula ture and removed from the body. In thismanner, the approach shown in FIG. 4 e accomplishes the formation offirst and second blood flow passageways 10 a and 10 b between thedesired blood vessels, in accordance with the present invention.

V. Methods and Apparatus for Controlling, Aiming and Guiding aTissue-Penetrating Element and/or Ancillary Devices Used to Form theExtravascular Passageway(s)

FIGS. 5 a- 5 l show examples of apparatus which may be utilized fororienting, aiming, controlling and/or guiding the tissue-penetratingelement 102 as it is advanced from the catheter 100 of the presentinvention, to create desired extravascular passageway 10. In general,these orienting, aiming, controlling and guiding apparatus are intendedto position the catheter 100 such that, when the tissue-penetratingelement 102 is passed out of the catheter 100 it will come into contactwith and penetrate the wall of the blood vessel within which thecatheter 100 is positioned. It is to be appreciated that the drawingsset forth in FIGS. 5 a-5 l and the following detailed description areprovided as mere examples of the types of orienting, aiming, controllingand/or guiding apparatus which may be utilized in the present invention,and are not intended to exhaustively show or describe all possibleapparatus which may be used for these purposes. Furthermore, it is to beunderstood that any or all of the apparatus shown in FIGS. 5 a- 5 l anddescribed herebelow may be combined with any other element of theinvention described herein to form a “system” whereby thepassageway-forming catheters 100 of the present invention may beoriented, aimed, controlled or guided.

FIG. 5 a shows one approach wherein an active imaging device 50 ispositioned within the same blood vessel as the catheter 100 of thepresent invention. This active imaging device 50 may comprise anysuitable type of catheter borne imaging device, including, but notlimited, to an intravascular ultrasound apparatus (IVUS catheter), aDoppler apparatus, an angioscope, etc. In many instances, the activeimaging device 50 will have a sensor (e.g., ultrasound transducer, sonictransducer, form image-receiving lens, etc.) formed at a specificlocation thereon. It will typically be desirable for such sensor 52 tobe located immediately adjacent the location at which thetissue-penetrating element 102 is to enter the blood vessel wall inorder to provide the desired observation, aiming and guidance of thetissue-penetrating element 102. It will be appreciated, that the activeimaging device 50 may be mounted upon or formed internally of thepassageway-forming catheter 100, may be carried within a monorail orsidecar formed on the catheter 100 (see FIGS. 9-10), or may be locatedwithin a wholly separate and discreet catheter body, as is shown in FIG.5 a. Embodiments of the a passageway-forming catheter device 100 whichincorporate means for mounting of at least a distal portion of theactive imaging device 50 within the passageway-creating catheter 100 arespecifically shown in FIGS. 9-10, and are fully described herebelow withreference to such figures.

One alternative approach for observing, aiming and guiding thetissue-penetrating element 102 is shown in FIG. 5 b, wherein the activeimaging device 50 is positioned within the blood vessel into which thetissue-penetrating element 102 of the, passageway-creating catheter 100will pass. As shown in FIG. 5 b, the sensor 52 of the imaging device 50may be located immediately adjacent the site at which the passageway 10is to be formed, such that the sensor 52 may aim and guide thetissue-penetrating element 102 as it extends from catheter 100, towardthe sensor 52 of the active imaging device 50.

FIG. 5 c shows another alternative approach which incorporates the useof a secondary imaging apparatus 54 (e.g., a passive or co-activeapparatus) in addition to the primary active imaging device 50. Thissecondary imaging apparatus may be formed on the passageway-creatingcatheter 100, or on the tissue-penetrating element 102 itself, and iscapable of communicating with or being sensed by the preliminary imagingapparatus 50. The primary imaging device 50, having a sensor 52 locatedthereon is positioned in the blood vessel adjacent that in which thepassageway-creating catheter 100 is located. The active imaging device50 will sense or communicate with the secondary imaging apparatus 54 soas to provide direct means for observing, aiming and guiding thetissue-penetrating element 102. In this embodiment, the secondaryimaging apparatus 54 may comprise any suitable type of substance orapparatus which is interrogable, imageable, or otherwise discernable bythe active imaging device 50. For example, the sensor 52 of the activeimaging device 50 may comprise a radio frequency transmitter and thesecondary imaging apparatus 54 on the passageway-creating catheter 100may comprise a radio frequency transponder which may be interrogated by,and will emit a responsive signal to, a radio signal emitted by theradio frequency transmitter of the active imaging device 50.Alternatively, in embodiments where the active imaging device 50 is afluoroscope, intravascular ultrasound (IVUS) device or Doppler, thesecondary imaging apparatus 54 on the passageway-forming catheter 100may comprise a radio opaque marker, reflective surface or soundingaperture from which radiation, sonic or ultrasonic energy may bereflected back to the active imaging device 50. Examples of the types ofsounding apertures or surfaces which may be formed on the body of thecatheter 100 or tissue-penetrating element 102 to enhance visualizationthereof by an active imaging device 50 are described in U.S. Pat. No.4,977,897 (Hurwitz).

FIG. 5 d shows a system wherein magnets 57 a, 57 b are mounted withinmodified passageway-forming catheters 101 a, and are used in conjunctionwith a tissue-penetrating guide wire 103 having a sharpened distal tip107, to form a passageway 10 between two blood vessels BV₁, BV₂ asshown, each of the catheters 101 a, 101 b has a magnet 57 a, 57 bmounted in one side thereof. Each magnet, and adjacent inserts formedwithin the catheter body has a hollow lumen 109 extending therethrough.In this manner, the lumenal openings in the magnets 57 a, 57 b may bepositioned in direct alignment with one another, utilizing theattractive force of the magnets 57 a, 57 b to accomplish such alignedpositioning. Thereafter, the tissue-penetrating guide wire 103 havingthe sharpened distal tip 107 may be advanced through the guide wirelumen 109 a of the first catheter 101 a and out of the lumenal openingin the magnet 57 a of that catheter 101 a, through the wall of the firstblood vessel BV₁, through any tissue located between the first bloodvessel BV₁, and the second blood vessel BV₂, through the wall of thesecond blood vessel BV₂ and into the lumenal opening of the magnet 57 bof the other passageway-forming catheter 101 b. In this manner, thetissue-penetrating guide wire 103 will have formed a passageway 10between the first blood vessel BV₁ and a second blood vessel BV₂. Itwill be appreciated that the distal tip 107 of the tissue-penetratingguide wire 103 may comprise a sharp distal tip which is retractable intothe guide wire such that the guide wire GW may remain within the bloodvessels after the catheters 101 a, 101 b have been removed.Alternatively, the tissue-penetrating guide wire 103 may be a laserwire, hot wire or any other type of tissue-penetrating member suitableto form the desired passageway 10.

FIGS. 5 e- 5 e′″ show methods and apparatus whereby passiveradiographically visible markers formed upon a passageway-formingcatheter 100 of the present invention, may be utilized to effect preciserotational positioning of the catheter 100 prior to formation of eachextravascular passageway 10. FIG. 5 e shows, in schematic fashion, apassageway-creating catheter 100 positioned within a first blood vesselBV₁ with the intention of forming a passageway 10 in accordance with thepresent invention from the first blood vessel BV₁ into an adjacenttarget T (e.g., a body cavity, mass of tissue or another blood vessel).A radiographic imaging apparatus 118 such as a fluoroscope or x-raydevice is utilized to provide a radiographic image of the first bloodvessel BV₁ and second blood vessel BV₂, on a screen 120 (e.g., an x-raycassette or fluoroscopy screen).

FIG. 5 e′ shows a catheter 100 having radiographically visible (e.g.,radio-opaque or radiolucent) markers 122 a, 122 b formed atlongitudinally spaced apart locations on opposite sides of the catheter100. These radiographically visible markers 122 a and 122 b arepreferably at equivalent elevational positions rela tive to the height Hof the catheter 100, but are spaced apart longitudinally, as shown.Thus, precise rotational positioning of the catheter 100 may be achievedby causing these radiographically visible markers 122 a, 122 b to becomedirectly aligned on the screen 120 at equivalent elevational positions,as shown in the lower side box of FIG. 5 e′.

FIG. 5 e″ shows another type of passive marking system which may beutilized to achieve precise rotational positioning of the catheter 100.With reference to FIG. 5 e″, the passageway-forming catheter 100 has acircular radiographically visible marking 124 on one side and a disk ordot shaped radiographically marking 126 on the other side, directlyopposite the circular marking 124. In this manner, precise rotationalpositioning of the catheter 100 may be achieved by causing the disk ordot shaped marking 126 to become positioned within the circular marking124, as viewed on the screen 120. This is illustrated in the lower sidebox of FIG. 5 e′.

Yet another type of radiographically visible marking which may beutilized to attain precise rotational positioning of the catheter 100 isshown in FIG. 5 e′″. With reference to FIG. 5 e′″, there is provided acatheter 100 having two (2) radiolucent apertures 128 a, 128 b ofsubstantially equivalent size, formed directly opposite one another, onopposite sides of the catheter 100. In this manner, precise rotationalpositioning of the catheter 100 may be achieved by rotating the catheter100 until the first and second radiolucent apertures 128 a and 128 bbecome directly aligned with one another such that they appear as asingle opening when viewed upon the screen 120, as illustrated in theside box of FIG. 5 e′″.

FIG. 5 f- 5 f′ show the manner in which an ultrasonically visiblemarking 130 formed upon the passageway-forming catheter 100 may beutilized in conjunction with an extracorporeally positioned ultrasoundimaging transducer 132 to effect precise rotational orientation of thecatheter 100. As shown, the ultrasonically visible marker 130 is formedat a specific location on the catheter 100, such specific locationhaving a known relationship to the site and direction in which thetissue-penetrating element 102 will pass from the catheter 100. Theextracorporeal ultrasound imaging transducer 132 is positioned on thebody so as to image both the blood vessel BV₁ wherein thepassageway-forming catheter 100 is positioned and the target (e.g.,second blood vessel, tissue mass, or other target location) into whichthe tissue-penetrating element 102 of the catheter 100 is to be passed.Thereafter, the catheter 100 is rotated until the ultrasonically visiblemarking 130 is clearly and completely imaged by the transducer 132. Suchpositioning of the ultrasonically visible marker 130 serves to establishthat the catheter has been placed in its proper rotational orientationto cause the tissue-penetrating element to pass into the target T.

FIGS. 5 g-5 g″ illustrate the manner in which passive markers on thepassageway-forming catheter 100 are utilized in conjunction with amagnetic resonance imaging (MRI) system, to effect precise longitudinaland rotational positioning of the catheter 100 as well as fordetermination of the distance between the blood vessel in which thecatheter 100 is located and the target T, so as to provide a means fordetermining the distance which must be traveled by thetissue-penetrating element 102 in order to form the desired passagewaybetween the blood vessel BV₁ and target T. In this embodiment, the bodyof the catheter 100 is formed of material which is visible by MRI.Additionally, a discrete MRI marker 134 is formed on the body of thecatheter, at a specific location. The marker may comprise an inductioncoil 134 a or a small mass of matter 134 b which differs from thematerial of which the catheter body 100 is formed so as to bespecifically visible on MRI.

With specific reference to FIG. 5 g′, the induction coil 134 a ispositioned on or within the wall of the catheter 100 at a specificlocation, and is connected by wires 135 which extend through thecatheter to an exterior location where they may be connected to asuitable current source, oscilloscope and/or other monitoring systemwhereby current, phase and amplitude of the electromagnetic field withinthe coil 134 a may be monitored. In this manner, movement of thecatheter 100 within the MRI scanner 135 will cause the location of thecoil 134 a to be altered within the variable but known magnetic fieldcreated by the MRI system. In this manner, each movement of the catheter100 within the MRI field will result in a change in current, phase andamplitude. The current phase and amplitude information received from thecoil 134 a may then be utilized to determine the precise location of thecoil 134 a relative to the target T. Moreover, if the coil 134 a becomeslocated out of the specific plane which is being imaged by the MRIscanner 135, such will indicate the catheter 100 has been longitudinallymoved out of the desired plane. In this manner, the coil 134 a may beutilized for precise longitudinal, and rotational orientation of thecatheter 100. Moreover, the information received from the coil 134 a maybe utilized to determine the exact distance between the coil 134 a andthe target T thereby providing information which will enable theoperator to control the tissue-penetrating element 102 in a mannerconsistent with the length of the passageway 10 to be formed.

With specific reference to FIG. 5 g″, an alternative MRI marker 134 bcomprises a discrete mass of material which differs from the material ofthe catheter body 100, and which is visible on MRI. In this manner, theMRI-visible marker 134 b may be precisely viewed on the MRI image, andmay be utilized to visually adjust the longitudinal or rotationalorientation and positioning of the catheter 100 relative to the targetT. Moreover, the viewed distance between the marker 134 b and the targetT may be utilized to enable the operator to control the passage of thetissue-penetrating element 102 to create a passageway 10 of the desiredlength between the blood vessel BV₁ within which the catheter 100 islocated and the target T.

Examples of specific types of “active” imaging apparatus which may beassociated with, mounted upon or incorporated into thepassageway-forming catheter 100 to facilitate precise rotationalorientation of the catheter 100 within a blood vessel, are shown inFIGS. 5 h-5 l.

With reference to FIG. 5 h, one type of active imaging apparatus whichmay be associated with, mounted upon or incorporated into thepassageway-forming catheter 100 is a Doppler apparatus 136, such as thatwhich is incorporated in a commercially availa ble devices known as theSmart Needle, Cardiovascular Dynamics, Inc., Sunnyvale, Calif.

With reference to FIG. 5 h, the Doppler apparatus 136 is mounted upon orwithin the catheter 100 and is aimed or directed in a 1 a teraldirection (e.g., perpendicular to the longitudinal axis of the catheter100). The Doppler apparatus 136 is useable to locate and discern a flowof fluid or other matter within the target T. Thus, the embodiment shownin FIG. 5 h is usable when target T comprises a blood vessel or otheranatomical structure wherein fluid or other matter is flowing. Theamplitude of the signal provided by the Doppler apparatus 136 and otherinformation discernable therefrom enables the operator to a)longitudinally position the catheter such that the Doppler apparatus 136is imaging the desired flow characteristics with in the target T (e.g,downstream of an obstruction and an artery), b) rotationally orient thecatheter such that the amplitude of the Doppler signal is peaked so asto indicate that the Doppler apparatus 136 is precisely aimed at thecenter of flow within the target T (e.g., the center of the lumen in ablood vessel) and c) determine the distance between the Dopplerapparatus 136 and the center of flow within the target T. Suchdetermination of the distance between the Doppler apparatus 136 and thecenter of flow (e.g., lumen center) within the target T will enable theoperator to control the tissue-penetrating element 102 such that thetissue-penetrating element 102 will pass or extend only the desireddistance from the catheter 100, thereby forming a passageway 10 into thecenter of flow (e.g., lumen) of the target but not traveling too far ascould puncture or perforate the contralateral side of the target T.

After the catheter 100 has been positioned in the first blood vesselBV₁, the Doppler apparatus 136 will be activated and the catheter 100will be moved longitudinally and/or rotated until the Doppler signal isindicative of the desired flow within the imaged portion of the target Tand such that the amplitude of the Doppler signal has peaked, therebyindicating that the Doppler apparatus 136 has been directly aligned withthe target T. Thereafter, the frequency output of the Doppler apparatus136 may be varied and the frequency which produces the peak amplituderesponse will indicate the distance from the Doppler apparatus 136 tothe target T. In this embodiment, the target T must be a blood vessel orother anatomical structure wherein flow of matter is present, so as tobe discerned by sonic (e.g., Doppler) means.

FIG. 5 i shows an embodiment wherein an intravascular ultrasound imagingapparatus 138 is positioned on the passageway forming catheter 100 at aspecific location on one side of the catheter 100. Such specificlocation of the ultrasound imaging apparatus 100 is preferably a knownlinear distance and known rotational distance away from the location atwhich the tissue-penetrating element 102 will pass out of the catheter100. After the catheter 100 has been positioned within a first bloodvessel BV₁, the catheter 100 may be rotated until the target T (e.g.,blood vessel, pulsating tissue, or other target locations visible byultrasound imaging) is in direct alignment, and is directly imaged by,the ultrasound apparatus 138, thereby indicating that the catheter 100has been longitudinally and rotationally oriented to cause thetissue-penetrating element 102 to pass through the wall of the firstblood vessel BV₁, and into the target T, as intended.

FIG. 5 j illustrates the manner in which a first transmitter/receiverwire 140a and a second transmitter wire 140 b may be utilized toaccomplish precise rotational orientation of the passageway-formingcatheter 100. As shown, the first transmitter or receiver wire 140 a ispositioned on or within the wall of the passageway-forming catheter 100at a specific location, on one side of the catheter 100. The location ofthis first transmitter or receiver wire 140 a is preferably immediatelyadjacent the location at which the tissue-penetrating element 102 willexit the catheter 100. A second transmitter or receiver wire 140 b ispositioned within the target T (e.g., second blood vessel, target tissueor other location into which the tissue-penetrating element of thepassageway-forming catheter 100 is to be passed). After the catheter 100has been advanced into the first blood vessel BV₁, the catheter will berotated while a signal is emitted from one transmitter or receiver wire140 a, 140 b such that such signal may be received by the othertransmitter or receiver wire 140 a, 140 b. In this manner, the cathetermay continue to be rotated until the amplitude of the signal received bythe receiving transmitter/receiver wire 140 a, 140 b is peaked, therebyindicating that the first transmitter/receiver wire 140 a and secondtransmitter receiver wire 140 b are at their closest point, therebyindicating that the catheter 100 has been positioned in its desiredrotational orientation within the first blood vessel BV₁. Additionally,one or both of the receiver wires 140 a, 140 b may be positioned in therespective blood vessel BV₁ and/or target area T to effect the desiredlongitudinal positioning of the catheter 100 within the blood vesselBV₁, when the monitored signal between the wires 140 a , 140 b soindicates.

FIG. 5 k shows alternative arrangement wherein induction coil 142 isformed upon or within the wall of the passageway-forming catheter 100 ata specific location which corresponds to the site from which thetissue-penetrating element 102 will exit the catheter 100. A transmitterwire 144 is positioned within the target T (e.g., second blood vessel,target tissue or other location into which the tissue-penetratingelement 102 of the catheter 100 is intended to pass) the transmitterwire 144 is energized so as to emit an electromagnetic signal and theinduction coil 142 is also energized. Thereafter, the catheter 100 isrotated until the phase and amplitude of the signal within the inductioncoil 142 indicates that the induction coil 142 is at its closest pointto the transmitter wire 100, thereby confirming that the catheter 100has been placed in its appropriate rotational orientation to cause thetissue-penetrating element 102 to pass from the catheter 100, throughthe wall of the first Bv₁, and into the target T.

FIG. 5 l illustrates the manner in which first and second magnets 146a-6 b may be utilized to effect precise rotational orientation of thepassageway-forming catheter 100. The first magnet 146 a is positioned onor within the wall of the passageway-forming catheter 100 at a specificlocation which corresponds to the site from. which thetissue-penetrating element 102 will exit the catheter 100. The secondmagnet 146 b is positioned on a second catheter 148 which is insertedinto the target T (e.g., second blood vessel, target tissue or otherlocation into which the tissue-penetrating element 102 is to be passed).The passageway-forming catheter 100 is then rotated, or is allowed toauto rotate) until the first magnet 146 a and second magnet 146 b are inalignment with and as close as possible to one another, therebyindicating that the passageway-forming catheter 100 has been placed inits correct rotational orientation to cause the tissue-penetratingelement 102 to pass through the wall of the first blood vessel BV₁ andinto the target T.

B. Devices of the Present Invention

FIGS. 6 through 12 show devices of the present invention which areuseable to form extravascular passageways 10 in accordance with thepresent invention, or to otherwise modify or equip such passageways 10.It is to be appreciated that the showings of FIGS. 6-12 and the detaileddescriptions set forth herebelow are intended to describe and illustratecertain examples and presently preferred embodiments of the devicesonly, and are not intended to exhaustively list and describe allpossible devices or embodiments in which the present invention may takephysical form.

i. Exit Schemes For Facilitating Passage of the Tissue-PenetratingElement Out of the Catheter

FIGS. 6 a-6 i show examples of arrangements and apparatus whereby atissue-penetrating element 102 useable to initially form anextravascular passageway 10 of the of the present invention, may bepassed out of a passageway-forming catheter 100 positioned within thelumen of a blood vessel such that the tissue-penetrating element 102will pass through the wall of the blood vessel in which the catheter 100is positioned, so as to create the desired extravascular passageway 10.

The detailed description of FIGS. 6 a-6 i set forth herebelow makesreference to various types of tissue-penetrating elements 102. The term“tissue-penetrating element” as used herein is intended to encompass allpossible types of elongate members which may be utilized to penetratetissue, devices or apparatus which may be utilized to penetrate tissue,or flows of energy (e.g., heat, laser beam, etc.) which may be used topenetrate tissue. Thus, when it is stated that the tissue-penetratingelement 102 is “passed” out of the catheter 100, such statement shallnot necessarily imply the passage of a solid element from the catheterbody, but may also include the operation of a tissue-penetratingapparatus or the passage of a flow of energy (e.g., heat, laser) fromthe catheter body in a manner and direction which will create thedesired extravascular passageway 10. Furthermore, it shall beappreciated that the showings of FIGS. 6 a-6 i and the descriptionprovided in conjunction with such figures is not intended to describe orillustrate all possible arrangements or apparatus by which thetissue-penetrating elements 102 may be passed out of thepassageway-forming catheters 100 of the present invention. Additionally,the following detailed description makes reference to sometissue-penetrating elements 102 which comprise a “pre-bent resilientmember”. The term “pre-bent resilient member” shall mean a member whichwhen unconstrained will assume a curved or curvelinear configuration butwhich is sufficiently flexible to be withdrawn into and constrained by alumen of the catheter device 100 without causing plastic deformation ofthe member. Examples of materials which may be utilized to form thepre-bent resilient members useable to form some of thetissue-penetrating elements 102 of the present invention includematerials which are resilient, elastic or superelastic at bodytemperature and within the range of other temperatures under which thedevice will be utilized. Examples of these materials include somestainless steels, some pla stics, and certain superela stic metal alloysand polymers such as nickel titanium alloys.

FIG. 6 a shows an embodiment of the passageway-forming catheter 10 awherein a lumen 112 a extends longitudinally through the catheter 100 aand terminates distally in a distal end aperture 114. Thetissue-penetrating element 102 comprises a pre-bent, resilient member,as defined hereabove. When retracted within the lumen 112, thisembodiment of the tissue-penetrating element 102 assumes a substantiallystraight, non-bent or minimally bent configuration in conformance to thesurrounding wall of the catheter 100 a. However, when thetissue-penetrating element 102 is advanced out of the outlet aperture114 a in the distal end of the catheter 100 a, the tissue-penetratingelement 102 will assume its pre-bent configuration such that the distalend of the tissue-penetrating element 102 will penetrate through thewall of the blood vessel wherein the catheter 100 a is positioned. It isto be appreciated with respect to this embodiment, and all otherembodiments of the invention herein described, that thetissue-penetrating element 102 may be configured to form any desiredshape and size of passageway 10. Thus, in embodiments wherein thetissue-penetrating element 102 comprises a pre-bent resilient member,the pre-bent configuration of the tissue-penetrating element may becontinuous curvelinear, partially straight and partially curvelinear,multicurvate, or any other pre-bent configuration which is suitable toform the initial extravascular passageway 10 of the desired size andshape. Furthermore, as described in more detail herebelow, variouspassageway modifying devices may be utilized to debulk, enlarge, dilateor otherwise modify the size and/or shape of the passageway such thatthe resultant final shape of the passageway 10 may differ substantiallyfrom that which is initially created by the first penetration of thetissue-penetrating element 102.

FIG. 6 b shows a passageway-forming catheter device having a lumen 112extending longitudinally therethrough and terminating distally in a sidewall outlet aperture 114 b. A deflector surface 115 is formed within thelumen 112 b, between the side wall aperture 114 b, and the contralateral surface of the lumen 112 b. A tissue-penetrating element 102formed of pliable material is of a substantially straight configurationwhen retracted within the lumen 112 b. However, when advanced in thedistal direction, the distal end of this tissue-penetrating element 102will be deflected by the deflector surface 115, and will exit the bodyof the catheter 100 b through side wall aperture 114 b. In this manner,the tissue-penetrating element may be caused to exit the body of thecatheter 100 b in a lateral direction relative to the longitudinal axisLA of the catheter 100 b.

FIG. 6 c shows a catheter device 100 c having a lumen 112 c extendinglongitudinally therethrough and terminating distally in a side walloutlet aperture 114 c. The tissue-penetrating element 102 may be apre-bent resilient member and is of a substantially straightconfiguration when fully retracted into the lumen 112 c of the catheter100 c. However, when this tissue-penetrating element 102 is advanced inthe distal direction, the distal end of such pre-bent resilient member102 will self-locate and pass out of the outlet aperture 114 c due toits inherent tendency to seek its pre-bent configuration, without anyneed for abutment against or deflection from any surface of the wall ofthe lumen 112 c.

FIGS. 6 d and 6 d′ show a catheter device 100 d which has a lumen 112 dextending longitudinally therethrough and terminating in a distal endoutlet aperture 114 d. An anvil member 180 is mounted a spaced distanceforward of the distal end of the catheter 100 d, and is attached to thecatheter by way of integrally formed struts 182. The anvil member 180has blunt distal surface 184, and a deflector surface 186 formed on theproximal side thereof, in direct alignment with the distal end outletaperture 114 d of the lumen 112 d of the catheter 100 d. Thetissue-penetrating element 102 in this embodiment may comprise either apliable member or resilient, pre-bent member which assumes asubstantially straight or minimally bent configuration which conforms toand is retractable into the lumen 114 d of the catheter, as shown.However, when the puncturing element 102 is advanced out of the distalend opening 114 d of the catheter, the distal tip of thetissue-penetrating element 102 will abut against the deflector surface186 of the anvil member 180, and will be thereby deflected, guided orcaused to bend or curve in the lateral direction, such that thetissue-penetrating element will pass through the wall of the bloodvessel BV, as shown.

Preferably, the deflector surface 186 of the anvil member 180 is notcontinuous with the inner surface of the lumen 112 d of the catheter 100d.

FIG. 6 e shows another embodiment of the catheter device 100 e whereinthe catheter device 100 e comprises a retractable outer catheter sheath190, and an elongate inner member 192 having a pre-bent, resilient tube194 formed within or mounted within the distal portion thereof. Theelongate inner member 192 has a blunt distal tip 196 and an elongateside opening 198 formed therein, such that when the outer cathetersheath 190 is retracted in the proximal direction, the pre-bentresilient tubular member 194 will spring outwardly to its pre-bent,laterally-curved configuration, as shown. The tissue-penetrating element102 of this embodiment may be a pliable member or a pre-bent resilientmember which will assume a pre-bent configuration when advanced out ofthe distal end opening 114 e formed in the distal end of the inner tubemember 194. In this manner, the pre-bent tube member 194 may form afirst angle, A₁ when the catheter sheath 190 is retracted in theproximal direction, and the pre-bent, resilient tissue penetratingelement 102 may form an additional second angle A₂ when it is advancedout of the distal end opening 114 e of the prebent tube member 194, suchthat the first angle A₁ and second angle A₂ will combine to form aresultant third angle A₃ between the direction in which the distal tipof the tissue-penetrating element 102 is aimed and the longitudinal axisLA of the catheter 100 e. As explained in detail hereabove, the angle A₃between the direction of the distal tip of the tissue-penetratingelement 102 and the longitudinal axis LA of the catheter 100 e does notnecessarily dictate or define the precise angle at which the passageway10 will be formed by the tissue-penetrating element 102. Indeed, thetissue-penetrating element 102 may be of any suitable configurationincluding a continuously curvelinear configuration which will create acontinuously curvelinear passageway.

FIG. 6 f shows another embodiment of the catheter device 100 f, whereinthe catheter device 100 f comprises a tubular outer sheath 202 which isretractable in the proximal direction, and an elongate inner member 204having a blunt distal tip 206 and a side opening 208 formed therein. Thetissue-penetrating element 102 is preferably a pre-bent resilient membermounted within the elongate member 104, immediately adjacent the sideopening 208 such that, when the outer catheter sheath 202 is advanced soas to cover the side opening 208, the tissue-penetrating element 102will assume a substantially straight or minimally bent configuration soas to conform to, and be contained within, the inner lumen 112 f of thecatheter device loof. However, when the outer sheath 202 is withdrawn inthe proximal direction so as to expose the side opening 208, thetissue-penetrating element 102 will spring outwardly to its pre-bentconfiguration such that the distal end of the tissue-penetrating elementwill be directed toward, or will be placed in immediate contact with,the wall of the blood vessel BV within which the catheter device 100 fis inserted. In at least some embodiments, the tissue-penetratingelement may thereafter be advanced in the distal direction so as topenetrate through the wall of the blood vessel and through anyextravascular tissue required to form the extravascular passageway 10 inaccordance with the present invention.

FIG. 6 g shows yet another embodiment of a passageway-forming catheterdevice 100 g comprising a tubular catheter body having a hollow lumen112 g extending longitudinally therethrough and opening distally througha distal end opening 114 g. The distal end of the body of the catheterlong is bendable in a lateral direction, as shown in the dotted lines ofFIG. 6 g. Such bending of the distal end of the catheter device 100 g inthe lateral direction, will cause the outlet aperture 114 g to becomedirected toward the wall of the blood vessel within which the catheterdevice 100 g is positioned, such that subsequent advancement of thetissue-penetrating element 102 out of the distal end opening 114 g ofthe catheter device 100 g will cause the tissue-penetrating element 102to contact and pass through the wall of the blood vessel BV within whichthe catheter device 100 g is positioned. The bendable distal end of thecatheter 100 g may be caused to transition from its straightconfiguration to its curved or bent configuration by the presence of ashape memory alloy, a pull wire, opposing electromagnetic coils or anyother suitable mechanism, apparatus or material known in the art forcausing the tip of a catheter to bend.

FIG. 6 h shows yet another embodiment of a passageway-forming catheterdevice looh comprising a tubular catheter looh having atissue-penetrating element 102 passable therefrom. An infla tableballoon 210 is formed on one side of the catheter device 100 h, oppositethe location at which the extra-vascular passageway 10 is to be formedin the wall of the blood vessel BV. Inflation of the balloon 210 priorto or during advancement of the tissue-penetrating element 102 will a)deter or prevent the catheter 10 h from recoiling and pressing againstthe contrala teral wall of the blood vessel BV as the tissue-penetratingelement 102 is advanced through the wall of the blood vessel BV, and b)may operate to stabilize and hold the distal portion of the catheterdevice 100 h in a substantially fixed position within the lumen of theblood vessel BV, so as to permit the application of an enhanced force orpressure upon the tissue-penetrating element 102 as it is advanced orotherwise passed through the wall of the blood vessel BV. In theembodiment shown in FIG. 6 h, the catheter device has a distal endoutlet opening 114 h and the tissue-penetrating element 102 is apre-bent resilient member which will assume a laterally bent or curvedconfiguration as it exits the distal end opening 114 h. It will beappreciated, however, that the side balloon 210 shown in FIG. 6 h may beincorporated and used in conjunction with any of the types of cathetersshow in FIGS. 6 a-6 i, including those wherein the tissue-penetratingelement exits through a side-outlet aperture formed in the side wall ofthe catheter device 100 h.

FIG. 6 i shows yet another embodiment of a passageway-forming catheterdevice 100 i comprising an elongate, flexible, tubular catheter bodyhaving a hollow lumen 114 i extending longitudinally therethrough and ablunt tip member 212 rotatably mounted on the distal end of the tubularcatheter body. The distal tip member 212 has a curved lumen 214extending therethrough, the proximal end of which is in alignment withthe lumen 114 i of the catheter 100 i. and the distal end of whichterminates in a side outlet aperture 114 i formed on one side of thedistal tip member 112. The tissue-penetrating element 102 in thisembodiment may comprise a pliable member or a resilient pre-bent member.In either instance, the tissue-penetrating element 102 may be initiallyadvanced to an intermediate position wherein the distal tip of thetissue-penetrating element is positioned within the curved lumen 214 ofthe distal tip member 212. With the tissue-penetrating element 102 insuch intermediate position, the tissue-penetrating element 102 may berotated. Such rotation of the tissue-penetrating element 102 will, dueto its frictional engagement within the curved lumen 214 of the distaltip member 121, cause the distal tip member 212 to concurrently rotate.In this manner, partial advancement and rotation of the tissuepenetrating element 102 may be utilized as a means for rotatably movingthe distal tip member 212 to adjust the rotational orientation of theside outlet aperture 114 i so as to direct the tissue-penetratingelement in the desired lateral direction to form the extravascularpassageway 10 of the present invention at the desired location. In thismanner, further advancement of the tissue-penetrating 102 out of theside outlet aperture 114 i, after the desired rotational orientation ofthe distal tip member 212 has been achieved, will cause thetissue-penetrating element to form the desired extravascular passageway10 through the wall of the blood vessel BV within which the catheterdevice 100 i is positioned.

ii. Types of Tissue-Penetrating Elements which may be Incorporated intothe Passageway-Forming Catheter

The following FIGS. 7 a-7 m and the accompanying detailed descriptionset forth herebelow are intended to describe and illustrate some typesof tissue-penetrating elements 102 which may be utilized in accordancewith the present invention. It is to be appreciated and understood thatthe specific types of tissue-penetrating elements 102 describedherebelow and shown in FIGS. 7 a-7 m are not intended to exhaustivelylist and explain all possible types of tissue-penetrating elements 102which may be useable but, rather, are intended to provide examples ofthe types of tissue-penetrating elements 102 which may be utilized. Asexplained hereabove, the term “tissue-penetrating element” is notlimited to solid members but may also include various devices,apparatus, or flows of energy. Furthermore, the term “resilient,pre-bent member” shall be interpreted in accordance with the definitionof such term set forth hereabove.

With reference to FIGS. 7 a-7 m, there are shown various types oftissue-penetrating elements 102 which may be incorporated into thepassageway-forming catheter 100 of the present invention. Thesetissue-penetrating elements 102 are designed to pass out of a flexiblecatheter body and to penetrate through the wall of the blood vesselwithin which the catheter 100 is located, and to adjacent extravasculartissue, as necessary, to form the desired extravascular passageway 10 ofthe present invention.

FIGS. 7 a and 7 a′ show a first embodiment of a tissue-penetratingelement 102 a. This embodiment of the tissue penetrating element 102 acomprises an elongate, pliable needle formed of a pliable material suchas polyimide tubing of the type availa ble commercially from MicroLumen,Inc., Tampa, Fla., and having a sharpened, beveled distal tip 300 formedthereon. An optional lumen 302 may extend longitudinally through thepenetrating element 102 a. A pre-bent, resilient member 304 ispositioned longitudinally within the tissue-penetrating element 102 a,or alternatively a pull wire.

When the element 102 a is retracted within the lumen of thepassageway-forming catheter 100, the resilient spine member 304 a willbe caused to assume a substantially straight or minimally bentconfiguration which conforms to the configuration of the catheter lumenand allows the tissue-penetrating element 102 a to be fully retractedwithin the catheter lumen. However, when the tissue-penetrating elementis exposed or advanced out of the passageway-forming catheter 100, adistal portion of the pre-bent spine member 304 will bend or curve in alateral direction, thereby causing the entire, pliabletissue-penetrating element 102 a to assume such laterally bent andcurved configuration, as designated by the phantom lines on FIG. 7 a. Inthis manner, the pre-bent resilient spine member 304 will cause thepliable or flexible body of the tissue-penetrating element to assume thedesired laterally bent or curved configuration. In some instances, thisarrangement may also allow the pliable body of the tissue-penetratingelement 102 a to be rotated or spun around the pre-bent resilient spinemember 304 a to facilitate or enhance advancement of thetissue-penetrating element through the blood vessel wall or adjacenttissue.

FIG. 7 b shows another embodiment of a tissue-penetrating element 102 bwhich comprises a pliable elongate proximal shaft 306 having a rigid,sharpened distal tip member 308 mounted upon, or otherwise joined to thedistal end of the proximal shaft 306. In this embodiment, the proximalshaft 306 of the tissue-penetrating element 102 b is sufficientlypliable and bendable to navigate tortuous anatomical curves or curveswithin the lumen of a catheter, while the rigid distal tip portion 308is formed of rigid material, such as stainless steel, so as to maintaina substantially sharp distal tip 310 which will penetrate and passthrough the blood vessel wall and desired extravascular tissue, to formthe extravascular passageway 10 in accordance with the presentinvention.

FIG. 7 c shows another embodiment of a tissue-penetrating element 102 cwhich comprises an elongate solid or hollow needle having a sharpeneddistal tip 312, and formed of a pre-bent resilient material such as asuperelastic nickel titanium alloy or other metal alloy which exhibitsresilient, elastic or superelastic properties within the range oftemperatures which the tissue-penetrating element 102 c will encounterduring normal use. This embodiment of the tissue-penetrating element 102c, being formed of pre-bent resilient material, will assume asubstantially straight or minimally bent configuration when retractedinto the lumen 112 of the passageway-forming catheter 100, such that theentire tissue-penetrating 102 c may be retracted into the lumen 112.However, when the tissue-penetrating element 102 c is advanced out ofthe outlet aperture 114 c in the catheter 100, the tissue-penetratingelement 102 c will assume its pre-bent configuration so as to becomecurved or bent in the lateral direction at an angle A relative to thelongitudinal axis LA of the catheter, thereby facilitating advancementof the distal portion of the tissue-penetrating element 102 c throughthe blood vessel wall and through any adjacent tissue to form thedesired extravascular passageway 10 in accordance with the presentinvention.

FIG. 7 d shows yet another embodiment of a tissue penetrating element102 d which comprises a hollow needle having a sharpened (e.g., beveled)distal tip 314 and a guide wire passage lumen 316 of extendinglongitudinally therethrough. It will be appreciated that this hollowneedle may be formed of either pre-bent, resilient material or pliablematerial, in accordance with the various tissue-penetrating element exitschemes illustrated in FIGS. 6 a-6 i and described in detail hereabove.The embodiment of the puncturing element 102 d shown in FIG. 7 d has theadvantage of permitting a guide wire GW to be advanced through the guidewire passage lumen 316. In this manner, the guide wire Gw may beperiodically advanced in the distal direction or may be placed undercontinuous distally directed pressure such that, when the sharpeneddistal tip 314 of the tissue-penetrating element 102 d enters the lumenof another blood vessel or another hollow cavity, the guide wire GW willrapidly advance in the distal direction, thereby signaling that thesharpened distal tip 314 of the tissue-penetrating element 102 d hasentered such blood vessel lumen or hollow cavity. Thus, this embodimentof the penetrating element 102 d is particularly useable in therevascularization. methods of the present invention wherein anextravascular passageway 10 is formed between two blood vessels, or inother extravascular procedures of the present invention wherein theextravascular passageway 10 is to be formed between a blood vessel and atarget T which comprises another blood vessel or other hollow cavity ofthe body. Distally directed pressure on the guide wire GW may be appliedmanually or by way of a pressure-exerting safety apparatus of the typeshown in FIGS. 10 c′, 10 c″ and 10 c′″ and described fully herebelow.

FIG. 7 e shows yet another embodiment of a tissue-penetrating element102 e comprising a solid needle having a sharpened (e.g., beveled)distal tip 318. This embodiment of the puncturing element 102 e may beformed of a continuous solid elongate member, such as a wire, asillustrated in FIG. 7 e′. Alternatively, as illustrated in FIG. 7 e″,this embodiment of the tissue-penetrating element may comprise an outertubular member 102 e″ having a hollow lumen 114 e″ extendinglongitudinally therethrough, and a removable solid stylet member 320inserted coaxially within the hollow lumen 114 e″ of the penetratingelement 102 e″ such that the tubular penetrating element 102 e″ incombination with the solid stylet member 320 will essentially form asolid needle structure similar to the solid elongate puncturing element102 e′, shown in FIG. 7 e′.

FIG. 7 f shows yet another embodiment of a tissue-penetrating element102 f which is made up of the combination of an elongate solid ortubular member 322 having a sharpened trocar tip 324 formed on thedistal end thereof, and a surrounding, longitudinally-advanceable outersheath 326. The distal portion of the outer sheath 326 may be tapered,not shown, such that it may pass over and shield the sharpened trocartip 324 of the elongate member 322. However, when being advanced throughthe blood vessel wall or other tissue, the sharpened trocar tip 324 willemerge out of the distal end opening of the outer sheath 326 so as topenetrate and advance through the blood vessel wall and/or other tissue.When the trocar tip has passed into another blood vessel lumen or otherhollow body cavity, the outer sheath 326 may be advanced in response tointermittent or continuous distally directed pressure applied to theouter sheath 326. Such distally directed pressure may be appliedmanually or by way of a continuous pressure-exerting safety device ofthe type shown in FIGS. 10 c′, 10 c″ and 10 c′″, as described fullyherebelow.

FIG. 7 g shows yet another embodiment of a tissue-penetrating element102 g which comprises an elongate tubular member 328 having an energyemitting distal tip 330 formed on the distal end thereof. One or moreenergy transmission wires or members 332 may extend through the tubularmember 328 and will be connected to the energy-emitting distal tip 330so as to deliver the desired form of energy to the distal tip 330. Inthis manner, the energy-emitting distal tip may emit any suitable typeof energy which will abla te, sever or facilitate advancement of themember 328 through a blood vessel and other extravascular tissue, inaccordance with the methodology of the present invention. Examples ofthe types of energy which may. be emitted from the energy-emittingdistal tip 330 include heat (e.g., electrical resistance heat or laserheat to form a “hot tip”), monopolar electrocautery, bipolarelectrocautery, ultrasound, etc.

FIG. 7 h shows yet another embodiment of a tissue-penetrating element102 h comprising an elongate flexible catheter 100 having a lumen 112extending longitudinally therethrough and a rotatable passageway-formingtip 336 mounted on the distal end thereof. A rotatable drive member 338extends longitudinally through the lumen 112 of the catheter 100, andoperates to rotate the distal tip 336 when it is desired to advance thetissue-penetrating element 102 h through the wall of a blood vessel orother tissue. The rotating distal tip 336 may be of any suitableconfiguration which, when rotated, will form a tunnel or passagewaythrough tissue of the desired configuration. In this regard, the outersurface of the rotatable tip 336 may be provided with a sharped spiralblade or threaded member 337 or other suitable tissue-cutting or dilating apparatus to facilitate the rotational boring, cutting or dila tionof tissue, desired of the rotatable tip 336.

FIG. 7 i shows yet another embodiment of a tissue-penetrating element102 i. In this embodiment, the tissue-penetrating element 102 icomprises a beam of pulsed or continuous laser light which is projectedout of an aperture or lens-covered port 114 i formed in the catheter100. A laser-transmitting element 340 such as a fiber optic extendslongitudinally through the lumen 112 of the catheter 100, and terminatesproximal to and in alignment with a reflective surface 341, such as amirror, from which the laser light emanating from the distal end of thelaser transmitting member 340 will be reflected out of the side apertureor port 114 i. Thus, in this particular embodiment, thetissue-penetrating element 120 i is not formed of solid matter ordeployable tissue penetrating apparatus, but rather, comprises a pulsedor continuous beam of laser light capable of vaporizing or ablating theblood vessel wall and other extravascular tissue to form the desiredextravascular passageway 10 of the present invention.

It will be appreciated that this embodiment of the tissue-penetratingelement 102 i may be modified in various ways. For example, in place ofthe reflective surface 341, a continuous energy guide (e.g., fiberoptic) may extend through the catheter body and terminate in an outletport or lens located on the side wall of the catheter, such that theflow of energy (e.g., laser light) will pass outward in the lateraldirection from the catheter. Alternatively, an energy-emitting apparatusmay be mounted on or within the side wall of the catheter so as to emitthe desired flow of energy in a lateral outward direction from thecatheter. Moreover, the embodiment specifically shown in FIG. 7 i andthe above-mentioned variations thereof shall not be limited to laserenergy, but may utilize any suitable flow of energy including heat,ultrasound, laser light, etc.

FIG. 7 j shows yet another embodiment of tissue-penetrating element 102j which may be incorporated into the passageway-forming catheters 100 ofthe present invention. In this embodiment, the tissue-penetratingelement 102 j comprises an elongate laser-transmitting member throughwhich laser energy may be passed such that the laser energy will emanateout of the distal end 343 of the elongate laser-transmitting member 102j. The elongate laser-transmitting member 102 j may be pre-bent suchthat if it is passed out of a distal end opening 114 in a catheter 100,it will automatically bend or curve in a lateral direction so as tocontact the wall of the blood vessel BV within which the catheter 100 islocated, to allow laser energy emanating from the distal end 343 of thelaser-transmitting member 102 j to form the desired extravascularpassageway 10 in the wall of the blood vessel and other extravasculartissue. Alternatively, it will be appreciated that various other exitsschemes may be utilized for the laser-transmitting member 102 j, such assidewall apertures formed in the catheter 100, in accordance with thesuitable exits schemes for all tissue-penetrating elements 102 asillustrated in FIG. 6 a-6 i and described fully hereabove.

FIG. 7 k shows yet another alternative embodiment of atissue-penetrating element 102 k usable in the passageway-formingcatheters 100 of the present invention. The tissue-penetrating element102 k shown in FIG. 7 k comprises an elongate hollow needle having alumen 316 extending longitudinally therethrough and having a sharpeneddistal tip. A vacuum source (e.g., suction) 344 is attached to theproximal end of the lumen 316 of the tissue penetrating element 102 k soas to draw or pull tissue into the lumen 316 as the distal end of thetissue-penetrating element is being advanced through the wall of theblood vessel BV or other tissue through which the extravascularpassageway 10 of the present invention is to be formed. An optionalsealing cuff 317, which may comprise an inflatable annular balloonmounted about the exterior of the tissue-penetrating element 102 k aspaced distance from the sharpened distal tip thereof, may be positionedin abutment with the wall of the blood vessel BV so as to form a sealwhich will prevent the suction applied to the lumen 316 from the leakingoutwardly or aspirating blood from the lumen of the blood vessel BV. Inthis manner, the optional sealing cuff 317 may facilitate drawing oraspiration of the tissue of the blood vessel wall BV or otherextravascular tissue into the distal end of the lumen 316 as thetissue-penetrating element 102 k is advanced through the tissue of theblood vessel wall or other extravascular tissue.

Yet another embodiment of a tissue-penetrating element 1021 useable inthe passageway-forming catheters 100 of the present invention, is shownin FIG. 7 l. With reference to FIG. 7 l, there is provided atissue-penetrating element 1021 formed by the combination of a standardtissue-penetrating element 102 such as a solid or hollow needle having asharpened distal tip, and a surrounding tubular sheath 346 having aresilient, pre-bent distal portion 347 and a hollow lumen 349 extendinglongitudinally therethrough. The sheath 346 having thetissue-penetrating element 102 mounted therewithin is advanced throughthe lumen 112 of the catheter 100. When the distal portion 347 of thesheath 346 is advanced out of the distal end opening 114 of the catheter100, the pre-bent distal portion 347 of the sheath will automaticallycurve or bend in a lateral direction, as illustrated by the dotted lineson FIG. 7 l. Thereafter, the pliable or pre-bent tissue-penetratingelement 102 will be advanced through the lumen 349 of the sheath 346,and through the wall of the blood vessel BV or other extravasculartissue to form the desired extravascular passageway 10 in accordancewith the present invention. Optionally, a vacuum source 345 may beconnected to the proximal end of the lumen 349 of the sheath 346 to drawthe wall of the blood vessel BV into contact with the distal end of thedistal portion 347 of the sheath 346, thereby facilitating efficientadvancement and penetration of the tissue-penetrating element 102through the blood vessel wall or other tissue.

Yet another embodiment of a tissue penetrating element 102 m is shown inFIG. 7 m. With reference to FIG. 7 m, there is provided a catheter 100having a side wall opening 114 formed therein and a hollow lumen 112extending longitudinally therethrough, and terminating at side wallopening 114. A tissue-penetrating element 102, such as a sharp-tiphollow or solid needle, is advanceable through the lumen 112 of thecatheter 100 and out of the side opening 114. A vacuum source 350 (e.g.,suction) is attached to the proximal end of the lumen 112 and suction isapplied, to draw the wall of the blood vessel BV downwardly and intocontact with the side aperture 114, as shown in FIG. 7 m. Suchsuction-induced contact of the wall of the blood vessel BV with the sideaperture 114 facilitates efficient advancement and penetration of thetissue-penetrating element 102 through the wall of the blood vessel BV,to create the desired extravascular passageway 10 in accordance with thepresent invention. Also, this suction attachment helps to hold thetissue which is being penetrated, in a taught state, therebyfacilitating penetration of such tissue.

iii. Passageway-Modifying Apparatus

FIGS. 8 a-8 h and the detailed description thereof set forth herebelowshow various types of apparatus which may be utilized to treat, enlarge,debulk, dilate, line, coat or otherwise modify the extravascularpassageway 10 initially formed by the tissue-penetrating element 102. Itis to be appreciated and understood that the showings of FIGS. 8 a-8 hand the following detailed description are impended to describe andillustrate representative examples of the types of passageway-modifyingapparatus which may be utilized in accordance with the presentinvention, and are not intended to exhaustively list and describe eachand every possible type of passage-modifying apparatus useable inaccordance with the present invention.

FIG. 8 a shows a first embodiment of a passageway modifying apparatus500 a comprising an elongate tubular member having an annular, sharpeneddistal cutting tip 502 formed on the distal end thereof, and a hollowlumen 504 a extending longitudinally therethrough. This embodiment ofthe passageway modifying apparatus 500 a may be advanced over a guidewire GW which has been passed through the initial passageway or tractcreated by the tissue-penetrating element 102, such that the annulardistal cutting tip 502 will debulk or enlarge the initial tract orpassageway formed by the tissue-penetrating element 102, so as toprovide an extravascular passageway 10 of the desired size andconfiguration. It will be appreciated that, suction or vacuum may beapplied to the proximal end of the lumen 504 a of this embodiment of thepassageway-modifying apparatus 500 a to facilitate the coring of tissueby the distal cutting tip 502 such that tissue which is severed by theannular distal cutting tip 502 will be drawn in the proximal directionthrough the lumen 504 a, and may be collected in an appropriatecollection vessel for subsequent pathological examination.

FIG. 8 b shows another embodiment of a passageway modifying apparatus500 b which comprises a tapered dila tor having a generally cylindricalproximal portion 506, and a gradually tapered distal portion 508. Ahollow lumen 504 b extends longitudinally through this embodiment of thepassageway modifying apparatus 500 b such that the passageway modifyingapparatus 500 b may be advanced over a guide wire GW which has beeninserted through the initial passageway or tract created by thetissue-penetrating element 102. As this passageway modifying apparatus500 b is advanced through such initially formed passageway or tract, thetapered distal portion 508 will dila te the passageway or tract to theenlarged diameter of the proximal portion 506 of the apparatus 500 b. Anoptional energy-emitting band 510 may be mounted about the proximalportion 506 of the apparatus 500 b, so as to emit heat or other energyto further modify the surface of the passageway 10 as the apparatus 500b is advanced therethrough.

FIG. 8 c shows a third embodiment of a passageway modifying apparatus500 c which comprises an elongate tubular member having an annular,sharpened distal cutting tip 512 which is similar to the distal cuttingtip 502 of the embodiment shown hereabove in FIG. 8 a, W but which isfurther adapted to emit energy (e.g, heat, vibration, laser light,etc.). In this embodiment of the apparatus 500 c, an energy transitionwire or member 514 extends through the tubular proximal portion of theapparatus 500 c and is connected to the annular distal cutting tip 512so as to transmit electrical energy, ultrasonic vibration, or any othersuitable form of energy to the distal tip 512, to facilitate advancementof the distal tip 512 to the desired blood vessel wall or otherextravascular tissue. The hollow lumen 504 formed through the apparatus500 c permits that apparatus 500 c to be advanced over a guide wirewhich has been positioned within the initially formed passageway ortract created by the tissue-penetrating member. Electrical current orother energy will be passed through the energy transmitting wire ormember 514 during advancement of the apparatus 500 c, such that heat orother energy is emitted by the distal tip to facilitate passage andadvancement of the apparatus 500 c through the tissue. It will beappreciated that a vacuum source (e.g., suction) may be attached to theproximal end of the lumen 504 c to further facilitate advancement of theapparatus 500 c through tissue, and to draw any cored tissue through thelumen 504 c such that the removed tissue may be collected in collectionvessel and submitted to subsequent pathological study.

FIG. 8 d shows a fourth embodiment of a passageway modifying apparatus500 d comprising an elongate tubular catheter 516 having a hollow lumen504 d extending longitudinally therethrough and an annular balloon 518mounted on the outer surface thereof. A separate balloon infla tionlumen (not shown) will extend through a proximal portion of the catheter516 to permit infla tion fluid to be injected into or withdrawn from theinterior of the balloon 518. This embodiment of the passageway modifyingapparatus 500 d may be advanced over a guide wire GW which has beenpositioned within the initial passageway or tract created by thetissue-penetrating element, until the deflated balloon 518 is positionedwithin such initially created passageway or tract. Thereafter, theballoon 518 may be inflated to dilate or stretch the initially formedpassageway or tract, to provide a modified extravascular passageway 10having the desired diameter and/or configuration.

FIG. 8 e shows a fifth embodiment of a passageway-modifying apparatus500 e which comprises an elongate pliable catheter body made up of aproximal portion 520′ and a distal portion 520″, positioned inlongitudinal alignment with one another. The proximal and distalportions 520′ and 520″ are connected to each other by two (2) elongate,bowable, cutting wires 522. A hollow lumen 504 e extends through theproximal 520′ and distal 520″ portions of the apparatus 500 e, such thatthe apparatus 500 e may be advanced over a guide wire GW which has beeninserted through the passageway or tract initially created by the tissueor penetrating element 102. A pull wire (not shown), or the guide wireitself may engage the distal portion 520″ of the catheter body such thatthe distal portion of the catheter body may be pulled in the proximaldirection, thereby decreasing the gap between the proximal portion 520′and distal portion 520″ of the catheter body. This will cause thecutting wires 522 to bow outwardly, as shown by the phantom lines onFIG. 8 e. In operation, the apparatus 500 e will be advanced over theguide wire GW and through the initially formed passageway or tract.Thereafter, the proximal portion 520″ of the catheter body will be drawnin the proximal direction to shorten the distance between the distal endof the proximal portion 520′ and distal portion 520″ of the catheterbody, thereby causing the cutting wires 522 to bow outwardly.Optionally, electrical current may be passed through the cutting wiressuch that the cutting action of the wires will be enhanced. Thereafter,the apparatus 500 e will be withdrawn in the proximal direction throughthe initially formed passageway or tract created by thetissue-penetrating element 102, such that the outwardly bowed cuttingwires 522 will enlarge the initially formed passageway or tract tothereby convert the passageway or tract into an enlarged slit-likeextravascular passageway 10, in accordance with the present invention.

FIG. 8 f shows a sixth embodiment of a passageway-modifying apparatus500 f which comprises an elongate shaft member 530 having a pull-backcutting apparatus 532 mounted on the distal end thereof. The pull-backcutting apparatus 532 comprises a rigid member having a blunt distalsurface 534 and an annular proximal cutting edge 536. A hollow lumen504f extends longitudinally through the shaft 530 and pull-back cuttingmember 532 such that the apparatus 500 f may be advanced over a guidewire GW which has been inserted in the initially formed passageway ortract created by the tissue-penetrating element 102. After the pull-backcutting member 532 has been fully advanced into the initially-formedpassageway or tract, it will be retracted in the proximal direction suchthat the proximal cutting surface 536 will cut away tissue so as toenlarge or debulk the passageway. Optionally, the cutting surface 536may be rotated during the retraction of the pull-back member 532 tofacilitate cutting of the tissue. Also, optionally, an anvil (not shown)may be positioned at the opposite end of the passageway 10 to providecounter-pressure against the cutting edge 536, thereby facilitating thecutting of tissue by the pull back cutting member 532. Tissue which issevered from the wall of the passageway by the proximal cutting surface536 will be collected within the interior chamber 538 of the pull-backcutting member 532.

FIG. 8 g shows a seventh embodiment of a passageway-modifying apparatus500 g which comprises an elongate shaft 540 having a push-forwardcutting member 542 mounted on the distal end thereof. A hollow lumen 504g extends longitudinally through the shaft 540 and cutting member 542such that the apparatus 500 g may be advanced over a guide wire GW whichhas been inserted through the initially-formed passageway or tractcreated by the tissue-penetrating element 102. The cutting member 542comprises a distal portion 542′ having a generally cylindrical outersurface and a proximal portion 542″ having an outwardly tapered outersurface. A sharpened annular cutting edge 544 is formed on the distalend of the distal portion 542′ such that, as the apparatus 500 g isadvanced in the distal direction, the cutting edge 544 will cut agenerally cylindrical mass of tissue, to thereby enlarge theinitially-formed passageway or tract through which the apparatus 500 gis advanced. Optionally, the sharpened annular cutting edge 544 of theapparatus 500 g may be rotated during the advancement of the apparatus500 g. Also, an optionally anvil (not shown) may be positioned at theopposite end of the passageway 10 to provide counter-pressure againstthe cutting edge 544, thereby facilitating the cutting of tissue by theapparatus 500 g.

FIG. 8 h shows an eighth embodiment of a passageway-modifying apparatus500 h. Comprising an elongate tubular member 550 having a lumen 504 hextending longitudinally therethrough. A plurality of outflow apertures554 are formed in the tubular member 550, within a region which is aspaced distance from the distal end of the tubular member 550. Also, adistal guide wire outlet aperture is formed in the distal end of themember 550 such that the apparatus 500 h may be advanced over a guidewire GW which has been inserted through an initially formed passagewayor tract created by the tissue-penetrating element 502. Proximal anddistal sealing balloons 552′, 552″ are formed about the outer surface ofthe tubular member 550, proximal and distal to the outflow apertures554. As show in FIG. 8 h″, the tubular member 550 may be advanced overthe guide wire GW until the outflow apertures 534 are located within thepassageway 10 which is to be treated with a flowable liquid substance.Thereafter, the annular sealing balloons 552′, 552″ will be inflated soas to seal off the opposite ends of the passageway 10. Thereafter, thedesired flowable substance will be passed through the lumen 504 h of thetubular member 550 such that it will flow out of the outflow apertures554 and will fill the interior of the passageway 10, which remainssealed by the sealing balloons 552′, 552″. After the flowable materialhas effected the desired treatment of the walls of the passageway 10,negative pressure may be applied to the lumen 504 h to withdraw theflowable material from the interior of the passageway 10. Thereafter,the sealing balloons 522′, 522″ will be defla ted and the apparatus 500h will be withdrawn and removed from the passageway 10. FIG. 8 h′ showsan alternative modification the device 500 h′ wherein no liquid outflowapertures 554 are formed on the tubular member 550, but rather, anenergy transmitting member (not shown) such as a wire will extendthrough the body of the tubular member 550 and the region of the tubularmember 550 between the sealing balloons 552′, 552″ will be equipped withan electrode, electrocautery apparatus, resistance heater, laser, orother energy emitting apparatus such that the outer surface of thetubular member 550 between the sealing balloon 552′, 552″ will becomeheated or will otherwise emit energy to treat the walls of thepassageway 10 when the apparatus 500 h″ becomes positioned within thepassageway, in the manner described hereabove with reference to FIGS. 5h and 8 h″.

iv. Apparatus for Longitudinal Compression and/or Support ofExtravascular Passageways Formed Between Two Blood Vessels

In those applications where the extravascular passageways 10 of thepresent invention are formed between two (2) blood vessels (as in manyof the above-described revascularization procedures) the presence ofcavernous or loose tissue between walls of the blood vessels may beproblematic, in that blood flowing through the passageway 10 may tend toinfiltrate into such cavernous or loose tissues, thereby giving rise toblood leakage and/or hematoma formation.

One means for deterring such infiltration of blood into tissue or spacebetween the adjacent blood vessel walls is the pla cement of alongitudinal passageway compression apparatus 22 within the passageway10 so as to compress such cavernous or loose tissue, thereby preventinginfiltration of blood thereinto. Furthermore, the deployment of suchlongitudinal compression apparatus 22 within the passageway 10 mayadditionally provide structural support within the passageway so as tomaintain the patency of the passageway and prevent the passageway fromunwanted flexing or closure due to movement of the adjacent tissues. Itwill be appreciated, however, that any such longitudinal compressionapparatus 22 will preferably be constructed so as to provide sufficientlongitudinal compression to prevent the unwanted infiltration of bloodinto the adjacent tissues but will not cause over-compression of suchtissues as could cause iatrogenic ischemia and possible necrosis of suchtissues. FIGS. 9 a-9 f′″ and the following detailed description of suchfigures are directed to examples of specific longitudinal compressionapparatus 22 which may be positioned within extravascular passageways 10of the present invention to prevent tissue infiltration of blood and/orto provide structural support within the passageway. It is to beunderstood that FIGS. 9 a-9 f′″ and the following detailed descriptionare not intended to exhaustively list and describe all possible types oflongitudinal compression apparatus 22 which may be useable in accordancewith the present invention. Rather, these figures and the followingdetailed description are mere examples of the types of longitudinalcompression apparatus 22 which are useable therefore.

The utility of the longitudinal compression apparatus 22 shown in FIGS.9 a-9 f′″ and described herebelow is not necessarily limitedextravascular passageways 10 of the present invention, but may also beuseable in connection with other methods for forming side-to-sideconnections (e.g., anastamoses) between juxtapositioned tubularanatomical passageways of the body such as blood vessels, fallopiantubes, etc.

FIGS. 9 a-9 a′ show a first embodiment of a longitudinal compressionapparatus 22 a which comprises a first annular member 600 and a secondannular member 602, which are directly alienable with one another andconnectable to one another so as to longitudinally compress the bloodvessel walls and other tissue which surround the passageway 10 formedbetween two blood vessels BV₁ and BV₂. The first ring member 600 has aplurality of leg members 604 which extend from one side thereof. Thesecond ring member 602 has a plurality of receiving apertures 606 whichare positioned and configured to receive the leg members 604therewithin. Each leg members 604 has a bayonet connector 608 or othertype of connector formed thereon such that, when the leg members 604become inserted into the receiving apertures 606, the connector 608 willengage corresponding members or surfaces formed within the receivingapertures 606 so as to lock and hold the first and second ring members600, 602 in a manner which causes longitudinal compression of theportions of the walls of blood vessels BV₁ and BV₂ and other interveningtissue which surrounds the passageway 10.

FIGS. 9 b-9 b′″ show as second embodiment of a longitudinal compressionapparatus 22 b which comprises a resilient (e.g., superelastic) wirering which has been bent into the configuration shown in FIG. 9 b havingtwo upper arcuate segments 610′, 610″ and two lower arcuate segments612′ and 612″, as shown. The apparatus 22 b is initially mounted withinthe lumen 614 of a tubular catheter 616. An inner catheter member 618having a reduced-diameter distal portion is coaxially positioned withinthe lumen 614 of the outer catheter 616, such that the longitudinallyextended lower arcuate portions 612′, 612″ of the apparatus 22 b arecaptured and frictionally engaged between the outer surface of thedistal reduced diameter portion of inner tubular catheter 618, and theinner luminal surface of the outer catheter 616, as shown in FIG. 9 b′.The outer catheter 616 is initially advanced through the passageway 10wherein the apparatus 22 b is to be deployed, and the inner catheter 616is then advanced in the distal direction to push the longitudinallyextended upper arcuate portions 610′, 610″ out of the distal end openingof the catheter 616, such that the upper arcuate portions 610′, 610″will resiliently bend outwardly so as to become positioned upon thelumenal surface of the first blood vessel BV₁. Thereafter, the innercatheter 618 is drawn backwardly to release the longitudinally extendedlower arcuate portions 612, 612′, 612″ form frictional engagement andcapture between the inner tubular catheter 618 and outer tubularcatheter 616, and the outer tubular catheter 616 is withdrawn such thatthe lower arcuate portions 612′, 612″ will pass out of the open distalend of the catheter 616 and will resiliently bend outwardly so as toabut against and engage the luminal surface of the second blood vesselBV₂, thereby compressing the walls of the blood vessels BV₁, and BV₂ andthe cavernous or loose tissue positioned therebetween, in the mannerillustrated in FIG. 9 b. The circular wire member of which the apparatus22 b is formed may be any suitable resilient type of material, andpreferably may comprise a nickel-titanium alloy or polymer whichexhibits superelasticity or high flexural properties within the range oftemperatures which will be encountered by the apparatus 22 b duringdeployment and impla ntation within the mammalian body.

FIG. 9 c shows a third embodiment of a longitudinal compressionapparatus 22 c comprising a first toroidal balloon 620 and a secondtoroidal balloon 622. The first and second toroidal balloons 620, 622are positioned in longitudinal alignment with one another and are joinedby a plurality of longitudinal connector members 624. The apparatus 22 cis initially positioned within the passageway such that the defla tedfirst toroidal balloon 620 is positioned adjacent the luminal surface ofthe first blood vessel BV₁ and the deflated second toroidal balloon 622is positioned adjacent the luminal surface of the second blood vessel622, with the connector members 624 extending longitudinally through thepassageway 10. Thereafter, the first and second toroidal balloons 620,622 are inflated so as to longitudinally compress the portions of thewalls of the blood vessels BV₁, and BV₂ and the tissue portions locatedtherebetween, surrounding the passageway 10, as shown in FIG. 9 c. Thetoroidal balloon member 620, 622 may be infla ted with a gelatinous orcurable polymeric substance which will fully or partially solidify afterthe toroidal balloon member 620, 622 have become inflated, therebyavoiding any problem with down-line leakage or defla tion of thetoroidal balloon member 620, 622.

FIG. 9 d shows a fourth embodiment of a longitudinal compressionapparatus 22 d which comprises an annular first magnet 626 and anannular second magnet 628 connected by a plurality of longitudinalconnector members 630. The apparatus 22 d is initially deployed withinthe passageway 10 such that the first annular magnet 626 is positionedadjacent the luminal surface of the first blood vessel BV₁ and thesecond annular magnet 628 is positioned adjacent the luminal surface ofthe second blood vessel BV₂. These annular magnets 626, 628 are thenallowed to magnetically move toward one another such that thelongitudinal connector members 630 will become engaged and willlongitudinally connect the magnets, thereby compressing the adjacentportions of the walls of blood vessels BV₁, BV₂ and any tissuepositioned therebetween, which surrounds the passageway 10.

FIG. 9 e shows a fifth embodiment of a longitudinal compressionapparatus 22 e comprising a first ring member 632 and a second ringmember 634, which may be compressed inwardly and connected by inflationof first and second balloons 640, 642. At least one connector member 636extends from the inner side of the first ring member 632. At least onecorresponding receiving aperture (not shown) is/are formed in the secondring member 634, and such receiving aperture(s) is/are sized andconfigured to receive the connector member(s) 636, and to engage rachetserrations or other engagable surfaces formed on the connector member(s)636. The apparatus 22 e is mounted within the passageway 10 by initiallyadvancing the catheter 638, with the balloons 640, 642, deflated,through the passageway until the upper ring member 632 is injuxtaposition to and abutment with the lumenal surface of the firstblood vessel BV₁, and the second ring member 634 is in juxtaposition toand abutment with the luminal surface of the second blood vessel BV₂.Thereafter, the balloon 640, 642 are simultaneously inflated so as tourge the ring members 632, 634 inwardly toward one another. As the ringmember 632, 634 are urged inwardly, the legs 636 of the first ringmember 632 will advance further into the receiving apertures of thesecond ring member 634 and the rachet serrations on leg 636 will befrictionally engaged and held within such receiving apertures (notshown). When the desired amount of compression of the walls of bloodvessels BV₁, BV₂, and tissue interposed therebetween and surrounding thepassageway 10 has been achieved, the balloons 640, 642 may be deflated,and the catheter 638 bearing the deflated balloons 640, 642 will bewithdrawn, leaving the apparatus 22 e in place within the passageway 10.

FIGS. 9 f-9 f″″ show a sixth embodiment of a longitudinal compressionapparatus 22 f which may be mounted within the extravascular passageway10 formed between two blood vessels BV₁, BV₂, in accordance with thepresent invention. As shown, this apparatus 22 f comprises a pluralityof substantially parallel, elongate, pre-bent, resilient wire members646 arranged in a generally cylindrical array. Optionally, a cylindricalconnector member 648 formed of rigid or pliable material may beconnected to each of the individual wire members 646 so as to hold themin the desired cylindrical array. Each wire member 646 is prebent sothat, when unconstrained, the opposite ends of each wire member 646 willcurl outwardly so as to cause the wire member to assume a generally “C”shaped configuration, as shown by the dotted lines in FIG. 9 f″.Initially, the apparatus 22 f is mounted within the lumen 652 of atubular delivery catheter 650. An inner tubular catheter member 654 ispositioned coaxially within the lumen 652 of the delivery catheter 650.The inner catheter 654 has a distal portion 656 of reduced outerdiameter. The apparatus 22 f is mounted within the lumen 652 of thedelivery catheter 656 such that the individual wire members 646 areconstrained and held in substantially straight configurations. Theproximal ends of the wire members 646 are captured between the outersurface of the distal portion 656 of the inner tubular catheter 654 andthe inner luminal wall of the outer catheter 650 as shown in FIG. 9 f′.The apparatus 22 f is implanted within the passageway 10 by initiallypassing the delivery catheter 650 into the passageway 10 such that thedistal end of the delivery catheter is flush with the lumenal surface ofthe first blood vessel as shown in FIG. 9 f′. Thereafter, the innertubular catheter 654 is advanced in the distal direction to cause thedistal ends of the wire members 646 to emerge out of the distal end ofthe outer catheter 650, thereby allowing the distal end of the wiremember 646 to curl outwardly and abut or become compressively insertedwithin the lumenal surface of the first blood vessel BV₁, as shown inFIG. 9 f′″. Thereafter, the inner catheter 654 is retracted slightly inthe proximal direction to release the proximal lens of the wire members646 from frictional engagement and capture between the distal portion656 of the inner tube 654 and the inner luminal surface of the outertube 650. Thereafter, the entire catheter 650 is retracted in theproximal direction thereby liberating the entire apparatus 22 f from theconstraint of the surrounding catheter 650 and allowing the proximalends of the wire members 646 to curl and to abut with or becomecompressively inserted into the luminal surface of the second bloodvessel BV₂. as shown in FIG. 9 f′″. In this manner, the apparatus, 22 fserves to compress the walls of the blood vessels BV₁, BV₂, and anytissue interposed therebetween, in the area surrounding the passageway10. Additionally, as shown in FIG. 9 f′″, it will be appreciated that inembodiments wherein the cylindrical connector member 648 is employed,such cylindrical connector member may comprise a segment of synthetic orbioprosthetic graft material so as to form a substantially tubular innerlining within the passageway 10, as illustrated in FIG. 9 f″″.

It will be appreciated that, although the apparatus 22 f has beendescribed hereabove as a pre-bent resilient structure, the wire members646 may alternatively be formed of malleable metal or otherpressure-deformable material and a suitable deformation tool such as aninflatable balloon may be deployed within the introducer catheter 650 soas to volitionally pressure-deform the ends of the wire members 646 asthey pass out of the “C” catheter tube 650, thereby providing thedesired pre-bent “C” shaped configuration.

V. A Preferred Passageway-Forming Catheter and System

FIGS. 10 a-11 d show two basic embodiments of a preferredpassageway-forming catheter, and accompanying apparatus which combine toform a passageway-forming system, in accordance with the presentinvention. FIGS. 12 a-13 b provide step-by-step showings of thepreferred method for utilizing the passageway-forming catheters andsystem shown in FIGS. 10 a-11 d, to create an extravascular passageway10 between two adjacent blood vessels BV₁, BV₂.

With reference to FIGS. 10 a- 10 c, there is shown a first embodiment ofa preferred passageway-forming catheter device 100 p, which comprises anelongate, flexible catheter body 700 having a lumen 702 extendinglongitudinally therethrough and terminating, at its distal end, in adistal outlet aperture 704. A tissue-penetrating element 102, which maycomprise any suitable tissue-penetrating element including any of thoseshown in FIGS. 7 a-7 k and described hereabove, is disposed within thelumen 702 of the catheter body 700. It will be appreciated that theoutlet aperture 704 and configuration of the lumen 702 may be modifiedto accommodate any of the suitable outlet schemes for passing thetissue-penetrating element out of the outlet aperture 704, includingthose penetrating-element outlet schemes shown specifically in FIGS. 6a-6 i, and described hereabove.

The flexible catheter body 700 is preferably formed of a flexiblepolymer material such as nylon, pebax, polyethylene, etc., or pliablemetal tubing such as a thin walled hypotubing. A metal braid or otherreinforcement material may be mounted upon or formed within the wall ofthe catheter body 700 to provide structural reinforcement and to permitthe catheter body 700 to be rotated or torqued without unduedisfigurement or crimping. Additionally, in embodiments wherein thetissue-penetrating element 102 comprises a pre-bent, resilient member orneedle, a rigid tubular reinforcement member 701 may be positioned abouta distal portion of the lumen 702 of the catheter body 700, as shown inFIG. 10 b, to provide rigid constraint for the pre-bent distal portionof the penetrating element 102 when the penetrating element 102 isretracted into the lumen 702 of the catheter body 700. The presence ofsuch tubular reinforcement member 701 will additionally prevent anysharpened distal tip on the tissue-penetrating element 102 from scarringor penetrating into the relatively soft plastic material of which thecatheter body 700 may be made.

A hand piece 706 is mounted on the proximal end of the pliable catheterbody 700. The handpiece 706 comprises a rigid outer shell having agenerally cylindrical, hollow inner cavity 712 formed therewithin. Aproximal portion of the tissue-penetrating element 102 extends into theinner cavity 712 of the handpiece 706. An actuator button 710 isconnected to the tissue-penetrating element 102, as shown in FIG. 10 c.The actuator button 710 may be depressed and advanced in the distaldirection to cause the tissue-penetrating element 102 to pass out of theoutlet aperture 704 for the purpose of forming an extravascularpassageway 10 of the present invention. Thereafter, the actuator button710 may be retracted in the proximal direction to retract thetissue-penetrating element into the lumen 702 of the flexible catheterbody 700.

Optionally, an imaging catheter side car 720 may be attached to thedistal portion of the flexible catheter body 700. This imaging catheterside car 720 comprises an elongate tube having a lumen 722 extendinglongitudinally therethrough. A window 724 is formed in the upper sidewall of the side car 720, immediately adjacent the outlet aperture 704.An imaging catheter 50, such as an intravascular ultrasound catheter ofthe types commercially available from Boston Scientific/CardiovascularImaging, MA; Endosonics, Inc., Pleasonton, CA: and Hewlett-Packard,North Andover, Mass., is insertable into the lumen 722 of the side car720 such that the sensor portion 52 (e.g., portion where the imagingultrasound is emitted and received) is positioned next to window 724.The material of which the side car 720 is made is preferably a materialwhich will prevent transmission of the type of energy (e.g., ultrasound)which is utilized by the imaging catheter 50, but the window 724 iseither an open aperture is covered with a material which may bepermeated by the energy utilized by the imaging catheter 50. In thismanner, the sensor portion 52 of the imaging catheter 50 will receive animage only of the area which is in alignment with the window 724.Additionally, the window 724 is preferably of a rectangularconfiguration and is confined to the side wall of the side car 720 whichis immediately adjacent the outlet aperture 704 of the flexible catheterbody 700. In this manner, such specific sizing, configuration andpositioning of the window 724 may permit the user to accomplish preciserotational orientation of the catheter apparatus 100 p by simplyrotating the apparatus 100 p until the target tissue (e.g., other bloodvessel) is clearly viewed by the imaging catheter 50 through the window724, thereby indicating that the outlet aperture 704 is positionedcorrectly so that subsequent passage of the tissue-penetrating element102 out of the outlet aperture 704 will cause the tissue-penetratingelement 102 to advance through the wall of the blood vessel in which thecatheter apparatus loop is located, and into the target tissue (e.g.,other blood vessel). Moreover, such positioning of the window 724 willpermit the imaging catheter 50 to be utilized to observe the actualmovement and penetration of the tissue-penetrating member 102, therebyensuring that the extravascular passageway is formed at the desiredlocation.

As an alternative to formation of a window 724 at a discrete locationwithin the side car 720, the distal end of the side car 720 may belocated adjacent the site at which the tissue penetrating member 102passes out of the catheter body 700 and the sensor portion 52 of theimaging catheter 50 may simply extend out of and beyond the distal endof the side car 720 such that it may clearly image the deployment andmovement of the tissue-penetrating element 102. In this alternativearrangement the field imaged by the imaging catheter 50 will no longerbe limited or inhibited by the window 724 and the imaging catheter 50may be capable of imaging in a full radius about the distal end of theside car 720. Accordingly, any suitable types of marker apparatus ormarking materials may be formed on the catheter apparatus 100 p ortissue-penetrating element 102 p to permit the imaging catheter 550 tobe utilized for the desired function of determining the correctrotational orientation of the catheter device 100 p prior to deploymentor actuation of the tissue penetrating element 102.

Additionally, as described hereabove, a guide wire lumen 726 may extendlongitudinally through the tissue-penetrating element 102 and mayterminate distally in a guide wire outlet aperture 728 formed in thedistal end of the tissue-penetrating element 102. In this manner, aguide wire GW may extend through the tissue-penetrating element 102 andmay be advanced out of guide wire outlet aperture 728.

In embodiments wherein the tissue-penetrating element 102 is providedwith a guide wire lumen 726 and guide wire outlet aperture 728 at itsdistal end, the presence of a guide wire GW within such lumen 726 may beutilized as a means for accurately determining when the distal end ofthe tissue-penetrating element 102 has penetrated into the lumen of atarget blood vessel or other cavity or open area. To accomplish this,continual or intermittent distally-directed pressure will be applied tothe guide wire GW as the tissue-penetrating element 102 is advancedthrough the wall of the blood vessel in which the catheter apparatus 100p is located and through any other extravascular tissue through whichthe passageway 10 is to pass. So long as the distal end of thetissue-penetrating element 102 is in abutment with tissue, the guidewire GW will be prevented from emerging and advancing out of the distalend guide wire outlet aperture 728 and, accordingly, the distallydirected pressure applied to the guide wire GW will be met withresistance due to the presence of the tissue abutting against the guidewire outlet aperture 728. However, when the distal end of thetissue-penetrating element 102 enters into the lumen of the target bloodvessel or other open space, the guide wire outlet aperture 728 willimmediately become uncovered and the guide wire GW will be permitted torapidly advance out of the guide wire outlet aperture 728 in response tothe distally directed pressure being applied thereto. Such rapidadvancement of the guide wire GW will signal to the operator that thedistal tip of the tissue-penetrating element 102 has, in fact, enteredthe lumen of the target blood vessel or other open space. At that point,advancement of the tissue-penetrating element 102 may be volitionallystopped, so as to avoid any possibility that the tissue-penetratingelement will perforate the contralateral wall of the target blood vesselor other tissue on the other side of open area within which thepassageway 10 is to extend.

FIG. 10 c′-10 c′″ provide a schematic illustration of an apparatus whichmay be incorporated into the passageway-forming catheter 100 p to exertcontinuous or intermittent distally directed pressure on the guide wireGW, as described hereabove, for determining when the distal end of thetissue-penetrating element 102 has passed into the lumen of the targetblood vessel or other open space. With reference to FIGS. 10 c′-10 c′″,the apparatus 800 comprises one or more springs 802 which are connected,by way of a connector member 804 to a portion of the guide wire GW whichprotrudes out of the proximal end of the catheter body 700. It will beappreciated that the apparatus 800 may be incorporated within the innercavity 712 of the handpiece 706, or may be formed as a separate unitwhich is mountable upon the proximal end of the handpiece 706.

As shown in FIG. 10 c, prior to commencement of the procedure, the guidewire GW may freely extend out of the outlet aperture 728 in the distalend of the tissue-penetrating element 102, thereby allowing the springmembers 802 of the apparatus 800 to assume a relaxed (e.g., shortened)configuration.

FIG. 10 c″ shows that, when the tissue-penetrating element 102 is beingadvanced through tissue, the distal end of the guide wire GW will bemaintained flush with the outlet aperture 728, and the spring members802 of the apparatus 800 will become stressed (e.g., elongated) due tothe distally-directed pressure being applied by the distal tip of theguide wire GW against the adjacent tissue.

FIG. 10 c′″ shows that, when the distal tip of the tissue penetratingelement 102 has emerged into the lumen of a blood vessel or other openarea, the guide wire GW will immediately advance out of the guide wireoutlet aperture 728, thereby allowing the spring members 802 of theapparatus 800 to once again assume their relaxed (e.g., shortened)configuration. This abrupt advancement of the guide wire and relaxationof the spring members 802 will signal to the operator, that thetissue-penetrating element 102 has arrived within the lumen of the bloodvessel or other open space, and that further advancement of thetissue-penetrating element 102 should be ceased.

As stated hereabove it shall be appreciated and understood that thepressure-exerting apparatus described and shown in FIGS. 10 c′-10 c′″ isoptional need not necessarily be included within the catheter deviceloop. Moreover, it shall be understood and appreciated that continuousor intermittent urging of the guide wire GW in the distal direction maybe accomplished manually (i.e., by hand) without the need for the use ofany apparatus.

FIGS. 11 a-11 d show the manner in which the preferredpassageway-forming catheter and system 100 p may be modified toaccommodate the specific type of tissue-penetrating element 102 f shownin FIG. 7 f and described hereabove. This particular tissue penetratingelement is made up of an inner puncturing member 322 and alongitudinally advanceable outer sheath 326.

FIGS. 11 a-11 d show a modified preferred catheter device 100 p′, which,like the above-described embodiment of the catheter device loop,comprises a flexible catheter body 700 having a lumen 702 extendinglongitudinally therethrough, a handpiece 706 having an inner cavity 712formed therewithin, and an imaging catheter side car 720 having a lumen722 and window 724 formed therewithin, all of which are described indetail hereabove.

In this embodiment of the catheter device 100 p′, the handpiece 706 ismodified to incorporate first and second actuator buttons 710 a, 710 b.The first actuator button 710 a is connected to the pre-bent resilientinner member 322 having the sharpened trocar tip 324 on the distal endthereof. The second actuator button 710 b is connected to the taperedpliable sheath 326 which is longitudinally advanceable over the innermember 322, in the manner described in detail hereabove with referenceto FIG. 7 f. Thus, in this modified embodiment of the catheter device100 p′, the inner member 322 and surrounding sheath 326 may beindependently advanced and retracted utilizing actuator button 710 a,710 b.

It will be appreciated that, when the inner member 326 is devoid anyguide wire lumen, it will be optional to apply continuous orintermittent distally directed pressure to the outer sheath 326 toaccomplish the same lumen-penetration-signaling function describedhereabove with reference to FIGS. 10 c′-10 c′″. Accordingly, theconstant or intermittent pressure spring apparatus 800 may be attachedto the sheath 326 in this embodiment of the catheter device 100 p′ so asto continuously urge the sheet 326 in the distal direction, in the samemanner described in the guide wire GW in FIGS. 10 c′-10 c′″, or such maye accomplished (if desired) by manual technique.

The catheter devices 100 and other devices and apparatus describedherein may be combined in various ways to form unique systems forperforming the methods of the present invention. The systems describedherein should be understood to be combinations of one or more of thevarious itemized functional components described. The components ofthese systems may be utilized in mechanical or temporal rela tionship toone another to accomplish the novel methods described herein, and may beused in any one of the numerous combinations possible that sufficientlyaccomplish the stated objectives. Such systems may include a catheterbody dimensioned to fit within a blood vessel and advanceable to alocation which is in proximity to an extravascular target or neighboringvascular target. The catheter can further be combined in some way withone or more of the described active or passive orientation means toassist in the proper positioning of the catheter in the blood vesselwith respect to the target. Further, the catheter may incorporate atleast one of the tissue-penetrating elements such that a passageway maybe formed from the blood vessel to the target. The system may alsoincorporate a guide wire dimensioned to be inserted into the passageway,and introducible through the catheter such that it may enter thepassageway and provide a rail to the target. The system may alsoincorporate the placement of one or more of the devices that arepositionable or insertable into the passageway over the guide wire, suchas channel sizing and maintenance means or other devices foraccomplishing a therapeutic or diagnostic end-point. Also, the systemsmay include one or more of the various blood vessel blocking means suchthat a blood vessel in operative association with an extravascularpassageway of the present invention may be blocked or occluded to allowthe re-routing of blood.

vi. Operation of the Preferred Embodiments of the Passageway-FormingCatheter and System

FIGS. 12 a-12 d provide a step-by-step showing of the preferred methodof using the first embodiment of the tissue-penetrating catheter deviceand system 100 p shown in FIGS. 10-10 c′″.

FIGS. 13 a-13 b provide a step-by-step showing of the preferred methodof using the second embodiment of the preferred passageway-formingcatheter device and system 100 p′.

With reference to FIGS. 12 a-12 d, an imaging catheter 50 is insertedinto the lumen 722 of the side car 720 such that the imaging sensorportion 52 of the catheter 50 is positioned adjacent window 724. In thismanner, the combination of the imaging catheter 50 with thepassageway-forming catheter device 100′ forms a “system” in accordancewith the present invention. With the tissue-penetrating element 102retracted into the lumen 704 of the flexible catheter body 700 such thatthe distal tip of the tissue-penetrating element 102 is housed withintubular reinforcement member 701, the system comprising the catheterapparatus 100 p and imaging catheter 50 is inserted into the vasculature of a mammalian patient and advanced until the distal end of thecatheter body 700 and distal end of the side car 720 are positionedwithin a first blood vessel BV₁ located adjacent a second blood vesselBV₂ with the invention of forming a passageway 10 between the firstblood vessel BV₁ and second blood vessel BV₂.

The catheter device 100 p is then rotated until the imaging field IFviewed by the imaging catheter 50 through the window 724 clearly viewsthe second blood vessel BV₂ into which the passageway 10 is to extend.This indicates that the catheter device 100 t has been placed in thecorrect rotational orientation to allow the tissue-penetrating element102 to form the passageway 10 at the desired location, such that it willextend into the second blood vessel BV₂. Thereafter, the actuator button710 will be advanced until the distal tip of the tissue-penetratingelement 102 begins to penetrate through the wall of the first bloodvessel BV₁. Optionally, intermittent or continuous distally directedpressure may be applied to the guide wire GW by hand (i.e., manually) orby a pressure-exerting apparatus 800, as advancement of thetissue-penetrating element 102 continues.

With reference to FIG. 12 b, as soon as the distal tip of thetissue-penetrating element 102 emerges into the lumen of the secondblood vessel BV₂, the guide wire GW will promptly advance in the distaldirection, thereby signaling to the operator that the advancement of thetissue-penetrating member 702 should be ceased. At that point, theoperator will discontinue further advancement of the actuator button710.

Thereafter, the actuator button 710 will be retracted to its fullproximal point so as to retract the tissue-penetrating element 102 intothe lumen 702 of the catheter body 700, while allowing the guide wire GWto remain extended through the newly-formed passageway 10 and into thelumen of the second blood vessel BV₂.

As show in FIG. 12 c, the passageway-forming catheter device loop andaccompanying imaging catheter 50 may then be extracted and removed fromthe body, leaving the guide wire GW positioned through the first bloodvessel BV₁, through the passageway 10 and into the second blood vesselBV₂.

As shown in FIG. 12 d, a passageway modifying apparatus 500, such as anyof the types of passageway modifying apparatus 500 shown in FIGS. 8 a- 8h, may then be advanced over the guide wire GB to modify (e.g., enlarge,debulk, treat, coat, etc.) the passageway 10.

It will be appreciated that, after the step shown in FIG. 12 v has beencompleted, the guide wire GW may be left in place through the passageway10 to allow any desired stents, stented grafts, or passagewayconstraining apparatus 22 as shown in FIGS. 9 a-9 f to be deployedwithin the passageway 10.

FIGS. 13 a-13 e illustrate a step-by-step preferred method for utilizingthe modified embodiment of the passageway-forming catheter device andsystem 100 p shown in FIGS. 11 a-11 b.

Initially, the desired imaging catheter 50 is inserted into the lumen722 of the side car 720 such that the imaging catheter 50 andpassageway-forming catheter device 100 p′ will, in combination, apassageway-forming “system”.

The passageway-forming catheter 100 p and accompanying imaging catheter50 are then advanced into the vascula ture to a point where the distalends of the catheter body 700 and side car 720 are positioned within afirst blood vessel BV₁ immediately adjacent a second blood vessel BV₂,between which a passageway 10 is to be formed. The imaging catheter 50is then energized such that the sensor portion 52 of the imagingcatheter will receive an image within the image field IF through window724. The catheter device 100 p′ is then rotated until the second bloodvessel BV₂ into which the passageway 10 is to extend is clearly imagedby the imaging catheter 50 through window 724. This indicates that thecorrect rotational orientation and position of the catheter device 100p′ has been attained. Additionally, the catheter device 100 p′ may belongitudinally moved until the desired flow characteristics are observedwithin the second blood vessel BV₂ in the image field IF, therebyindicating that the catheter device 100 p is in its correct longitudinalposition. Additionally, the imaging catheter 50 may be utilized todetermine the distance between the first blood vessel BV₁ and secondblood vessel BV₂, so as to define the distance which thetissue-penetrating element 102 f should be deployed to form the desiredpassageway 10 from the first blood vessel BV₁ to the second blood vesselBv₂.

As shown in FIG. 13 a, after the catheter 100 p′ has been longitudinallyand rotationally orientated, the tissue-penetrating element 102 f isdeployed out of the catheter body 700, and begins to advance through thewall of the first blood vessel BV₁. The outer sheath 326 of the tissuepenetrating element 102 f will be in a slightly retracted position suchthat the trocar tip 324 extends out of the distal end of the sheath 326to accomplish the desired penetration through tissue.

During the advancement of the tissue-penetrating element 102 f as shownin FIG. 13 a, manual pressure or pressure exerted by apparatus 800 maybe utilized to apply distally directed pressure to the sheath 326. Inthis manner, when the trocar tip 324 of the tissue-penetrating element102 f enters the lumen of the second blood vessel BV₂, the sheath 326will immediately advance forwardly into the lumen of the second bloodvessel BV₂, thereby signaling to the operator that the desiredpassageway 10 has been formed and that any further advancement of thetissue-penetrating element 102 f should be ceased.

FIG. 13 b shows that, after the sheath 326 has advanced into the lumenof the second blood vessel BV₂, the elongate trocar tipped member 322may be extracted and removed, thereby leaving the sheath 326 as aconduit through the passageway 10.

As shown in FIG. 13 c, a guide wire GW may then be passed through thelumen of the sheath 326 and into the second blood vessel BV₂.

Thereafter, as shown in FIG. 13 d, passagewayforming catheter device 100p′ and accompanying imaging catheter 50 may be extracted and removedfrom the body, thereby leaving the guide wire GW in place, and extendingthrough the lumen of the first blood vessel BV₁, through the passageway10 and into the second blood vessel BV₂.

Thereafter, as shown in FIG. 13 e, any suitable type ofpassageway-modifying apparatus 500 may be advanced over thepre-positioned guide wire GW to effect the desired modification of thepassageway 10.

It will be appreciated that the invention has been described hereabovewith reference to certain specific embodiments and examples only. Noeffort has been made to exhaustively describe all possible embodimentsof the invention, or to provide examples of each and every way in whichthe invention may be practiced. Indeed, those skilled in the art willrecognize that various additions, deletions, modifications andalterations may be made to the above-described embodiments and exampleswithout departing from the intended spirit and scope of the invention.Accordingly, it is intended that all such additions, deletions,modifications and alterations be included within the scope of thefollowing claims.

1. A method for revascularization, said method comprising the steps of:a) choosing a first location on a blood vessel that has a lumencontaining blood having a pO₂ of at least 50; and b) forming apassageway that extends outside of said lumen and between said firstlocation and a second location on a blood vessel, such that said bloodwill flow through said passageway, said passageway being formed by i)providing a passageway-forming catheter device that comprises anelongate flexible catheter body having a tissue-penetrating elementpassable therefrom; ii) inserting said catheter body into the bloodvessel lumen and positioning said catheter body within the blood vessellumen such that the tissue-penetrating element is located adjacent thelocation at which said passageway is to be formed; and iii) passing saidtissue-penetrating element from said catheter body so as to form saidpassageway such that blood will flow from the first location through thepassageway and to the second location.
 2. The method of claim 1 whereinsaid first location and said second location are located in the coronaryvasculature.
 3. The method of claim 1 wherein said first location andsaid second location are on the same blood vessel.
 4. The method ofclaim 1 wherein step a comprises choosing a location upstream of anobstructed, injured or diseased segment of a blood vessel, and whereinsaid second location is downstream of the obstructed, injured ordiseased segment, such that the blood bypasses the segment.
 5. Themethod of claim 1 wherein at least one of said first and secondlocations is on a blood vessel which is part of a system of bloodvessels wherein an obstructed, injured or diseased segment of a bloodvessel is present, and wherein step b comprises forming the passagewayso as to deliver the blood to a region that has been deprived of bloodbecause of the obstructed, injured, or diseased segment.
 6. The methodof claim 1 wherein part of Step b further comprises: providing andusingan orientation means for locating said first and second locationsand for orienting the catheter device such that the tissue-penetratingelement of the catheter will pass from said first location to saidsecond location, thereby forming said passageway between said firstlocation on a blood vessel and said second location on a blood vessel.7. The method of claim 1 wherein the tissue penetrating element ofthedevice provided in part step b further incorporates a lumen throughwhich a guide wire maybe passed upon creation of said passageway by saidtissue-penetrating element, and wherein said method further comprisesthe step of: passing a guide wire through said lumen and allowing saidguide wire to remain extended through said passageway followingextraction and removal of said catheter, to thereby provide forsubsequent advancement of one or more other apparatus through saidpassageway, over said guide wire.